Compass Life Sciences are continuing to support an exciting and rapidly growing specialist CRO and consultancy that following recent acquisition are investing in growing their Regulatory Affairs consulting group. As part of this injection of investment, we are searching for a number of Regulatory Affairs Managers to join a team that provide expert and high quality services to the biotech and pharmaceutical sector. The Role Supporting a range of assigned clients, your day to day role will be varied, and offer a range or responsibilities supporting clients from many different aspects. You will oversee regulatory review and gap analysis of dossiers, and write / review sections of dossiers for Centralised, Decentralised, and National Procedures. Other duties include; Preparation & project management of Marketing Authorisation Applications (MAA) Writing and review all types of simple & complex variations Author/Update/Review PI texts (and Co-ordinate Linguistic review processes as required) Co-ordinate licensing and post licensing procedures on behalf of clients Line-management of junior staff, where appropriate and agreed with direct report and/or Senior Management Team. Training and delegation of tasks to junior staff Project Management/lead responsibilities Write and review SOP's/processes (as required) Requirements To be considered for this role, our client is looking for candidates that are able to display the following skills, experience, and qualifications; 2:1 (or above) graduate in relevant scientific discipline (or equivalent experience or PhD) Significant broad & deep regulatory affairs experience Strong understanding of the regulatory environment including guidelines In depth knowledge of all application types Understanding of Mutual Recognition, Decentralised and Centralised procedures Ability to work under pressure and achieve timely submission and regulatory approvals Knowledge of International Regulatory Affairs would be an advantage, but not essential Confident/Enthusiastic/Outgoing with the ability to work on their own or as part of a team Self-motivated with excellent communication skills Well organized and good planning abilities with a good eye for detail Next Steps To gain further information, or to apply, please contact David Jolley at or call (0) or (0). Compass Life Sciences is a trading name of Compass Associates Ltd, and are acting as a Recruitment Consultancy for this permanent vacancy.
Apr 16, 2021
Full time
Compass Life Sciences are continuing to support an exciting and rapidly growing specialist CRO and consultancy that following recent acquisition are investing in growing their Regulatory Affairs consulting group. As part of this injection of investment, we are searching for a number of Regulatory Affairs Managers to join a team that provide expert and high quality services to the biotech and pharmaceutical sector. The Role Supporting a range of assigned clients, your day to day role will be varied, and offer a range or responsibilities supporting clients from many different aspects. You will oversee regulatory review and gap analysis of dossiers, and write / review sections of dossiers for Centralised, Decentralised, and National Procedures. Other duties include; Preparation & project management of Marketing Authorisation Applications (MAA) Writing and review all types of simple & complex variations Author/Update/Review PI texts (and Co-ordinate Linguistic review processes as required) Co-ordinate licensing and post licensing procedures on behalf of clients Line-management of junior staff, where appropriate and agreed with direct report and/or Senior Management Team. Training and delegation of tasks to junior staff Project Management/lead responsibilities Write and review SOP's/processes (as required) Requirements To be considered for this role, our client is looking for candidates that are able to display the following skills, experience, and qualifications; 2:1 (or above) graduate in relevant scientific discipline (or equivalent experience or PhD) Significant broad & deep regulatory affairs experience Strong understanding of the regulatory environment including guidelines In depth knowledge of all application types Understanding of Mutual Recognition, Decentralised and Centralised procedures Ability to work under pressure and achieve timely submission and regulatory approvals Knowledge of International Regulatory Affairs would be an advantage, but not essential Confident/Enthusiastic/Outgoing with the ability to work on their own or as part of a team Self-motivated with excellent communication skills Well organized and good planning abilities with a good eye for detail Next Steps To gain further information, or to apply, please contact David Jolley at or call (0) or (0). Compass Life Sciences is a trading name of Compass Associates Ltd, and are acting as a Recruitment Consultancy for this permanent vacancy.
Compass Life Sciences are continuing to support an exciting and rapidly growing specialist CRO and consultancy that following recent acquisition are investing in growing their Regulatory Affairs consulting group. As part of this injection of investment, we are searching for a number of Senior Regulatory Affairs Officers to join a team that provide expert and high-quality services to the biotech and pharmaceutical sector. The Role In this varied role, you will be involved in a range of varied activities each day across a portfolio of global pharmaceutical and biotech clients. You will be responsible for the management of project work and work as the project lead for assigned Clients. In addition to this you will be responsible for a number of activities including; The preparation, coordination and review of documentation or dossiers Preparation & project management of Marketing Authorisation Applications (MAA) Authoring of CMC documentation and responses to questions, as required Preparation, update or review of PI texts (including coordinating linguistic review processes) Preparation and authoring and/or review of post-approval submissions (e.g. variations, renewals, PSURs, artwork updates) Supporting PIL user testing activities Requirements To be considered for this role, our client is looking for candidates that are able to display the following skills, experience, and qualifications; 2:1 (or above) graduate in a relevant scientific discipline Broad & deep regulatory affairs experience Strong understanding of the EU regulatory environment including guidelines Practical knowledge of EU application types Sound understanding of Mutual Recognition, Decentralised and Centralised procedures (preferably from hands-on experience) Ability to work under pressure and achieve timely submission and regulatory approvals Good analytical & problem-solving skills Next Steps To gain further information, or to apply, please contact David Jolley at or call (0) or (0). Compass Life Sciences is a trading name of Compass Associates Ltd, and are acting as a Recruitment Consultancy for this permanent vacancy.
Apr 16, 2021
Full time
Compass Life Sciences are continuing to support an exciting and rapidly growing specialist CRO and consultancy that following recent acquisition are investing in growing their Regulatory Affairs consulting group. As part of this injection of investment, we are searching for a number of Senior Regulatory Affairs Officers to join a team that provide expert and high-quality services to the biotech and pharmaceutical sector. The Role In this varied role, you will be involved in a range of varied activities each day across a portfolio of global pharmaceutical and biotech clients. You will be responsible for the management of project work and work as the project lead for assigned Clients. In addition to this you will be responsible for a number of activities including; The preparation, coordination and review of documentation or dossiers Preparation & project management of Marketing Authorisation Applications (MAA) Authoring of CMC documentation and responses to questions, as required Preparation, update or review of PI texts (including coordinating linguistic review processes) Preparation and authoring and/or review of post-approval submissions (e.g. variations, renewals, PSURs, artwork updates) Supporting PIL user testing activities Requirements To be considered for this role, our client is looking for candidates that are able to display the following skills, experience, and qualifications; 2:1 (or above) graduate in a relevant scientific discipline Broad & deep regulatory affairs experience Strong understanding of the EU regulatory environment including guidelines Practical knowledge of EU application types Sound understanding of Mutual Recognition, Decentralised and Centralised procedures (preferably from hands-on experience) Ability to work under pressure and achieve timely submission and regulatory approvals Good analytical & problem-solving skills Next Steps To gain further information, or to apply, please contact David Jolley at or call (0) or (0). Compass Life Sciences is a trading name of Compass Associates Ltd, and are acting as a Recruitment Consultancy for this permanent vacancy.
As the Regulatory Affairs Manager for Halewood Chemicals, you'll have a high-level of responsibility, broad-focus and have the chance to shape a growing pharmaceutical business. You'll lead and execute the business' regulatory strategy and plans. You'll be responsible for all regulatory affairs related to the company's marketing authorisations. Meanwhile, you'll carry out management duties for the regulatory team of 3 full-time staff and contractors, helping coach and lead them. Your entrepreneurial drive and expert knowledge will drive forward the business. Working for a small, family-owned business, you will become a key voice, from day one, in deciding the strategic direction of the company. *Minimum Qualifications:* * A relevant bachelor's degree (master's degree or Ph.D. degree preferred). * Minimum of 8 years industry experience. * Previous experience in a similar sized SME business. * Previous experience updating technical files and design dossiers. * Demonstrable knowledge of MHRA, EEA, ASEAN Regulations and other international regulations pertaining to the design, manufacture and commercialization of generic pharmaceutical finished products required. *Preferred Qualifications:* * Previous experience in the development of regulatory strategies. * Previous experience interacting with international Health Authorities. * Previous project management / project lead experience. * Ability to think strategically, taking in the bigger picture and setting aims and objectives to develop and improve the business. * Proven ability to multi-task and manage multiple projects while paying attention to detail. * Proactive, independent worker who is highly organised and interested in the difference they can make through their individual contribution. *Responsibilities:* * Responsible for all regulatory affairs related to the company's generic finished product marketing authorisations. * Prepare MHRA and international submissions for new product licenses and license changes, as required, to ensure timely approval for market release. * Communicate directly with international affiliates and regulatory agency personnel. * Provide support to currently marketed products as necessary. This includes reviewing labelling, promotional material, and other post-market activities. * Support Product and Manufacturing changes as necessary. This requires development of regulatory strategies, creating and submitting change notifications to regulatory agencies, updating technical files and design dossiers. * Ensure regulatory affairs files are maintained to support compliance with regulatory requirements. * Support internal and external audits by regulatory agencies as required. * Actively works and communicates with customers and partners. * Lead and execute the businesses regulatory strategy and plans. * Work with the managing director to help define company strategy, growth trajectory and investment decisions. * Understand requirements & implications of changes within the business and the regulatory impact these will have and develop plans in response. * Carries out management responsibilities for the regulatory team * Including interviewing, and training employees; planning, assigning, and directing work. * Liaise with all regulatory contractors. *Compensation: *£40K - £55K, depending on experience (+ a performance-based annual bonus). *Employment Type:* Full-time, based at our office (with some work from home flexibility when necessary). *Job Location:* The Mill, Horton Road, Stanwell Moor, Surrey, TW19 6BJ, United Kingdom. *About Halewood Chemicals: *Halewood Chemicals is a producer & distributor of generic pharmaceuticals and raw materials. Based in the United Kingdom, we export all over the world. Founded as a wholesaler of medicines and raw materials, Halewood has since expanded into the development and licensing of own brand generic pharmaceutical finished products and over-the-counter (OTC) healthcare products. The Halewood Chemicals Group was formed by Dr Gordon James Pritchard in 1947. Over the past 70 years, the group has provided healthcare products to healthcare professionals all over the world - from small projects to national tenders. To this day it continues to be a family business, with Dr Pritchard's daughter, Mrs Susan de Zulueta, the current managing director.
Apr 16, 2021
Full time
As the Regulatory Affairs Manager for Halewood Chemicals, you'll have a high-level of responsibility, broad-focus and have the chance to shape a growing pharmaceutical business. You'll lead and execute the business' regulatory strategy and plans. You'll be responsible for all regulatory affairs related to the company's marketing authorisations. Meanwhile, you'll carry out management duties for the regulatory team of 3 full-time staff and contractors, helping coach and lead them. Your entrepreneurial drive and expert knowledge will drive forward the business. Working for a small, family-owned business, you will become a key voice, from day one, in deciding the strategic direction of the company. *Minimum Qualifications:* * A relevant bachelor's degree (master's degree or Ph.D. degree preferred). * Minimum of 8 years industry experience. * Previous experience in a similar sized SME business. * Previous experience updating technical files and design dossiers. * Demonstrable knowledge of MHRA, EEA, ASEAN Regulations and other international regulations pertaining to the design, manufacture and commercialization of generic pharmaceutical finished products required. *Preferred Qualifications:* * Previous experience in the development of regulatory strategies. * Previous experience interacting with international Health Authorities. * Previous project management / project lead experience. * Ability to think strategically, taking in the bigger picture and setting aims and objectives to develop and improve the business. * Proven ability to multi-task and manage multiple projects while paying attention to detail. * Proactive, independent worker who is highly organised and interested in the difference they can make through their individual contribution. *Responsibilities:* * Responsible for all regulatory affairs related to the company's generic finished product marketing authorisations. * Prepare MHRA and international submissions for new product licenses and license changes, as required, to ensure timely approval for market release. * Communicate directly with international affiliates and regulatory agency personnel. * Provide support to currently marketed products as necessary. This includes reviewing labelling, promotional material, and other post-market activities. * Support Product and Manufacturing changes as necessary. This requires development of regulatory strategies, creating and submitting change notifications to regulatory agencies, updating technical files and design dossiers. * Ensure regulatory affairs files are maintained to support compliance with regulatory requirements. * Support internal and external audits by regulatory agencies as required. * Actively works and communicates with customers and partners. * Lead and execute the businesses regulatory strategy and plans. * Work with the managing director to help define company strategy, growth trajectory and investment decisions. * Understand requirements & implications of changes within the business and the regulatory impact these will have and develop plans in response. * Carries out management responsibilities for the regulatory team * Including interviewing, and training employees; planning, assigning, and directing work. * Liaise with all regulatory contractors. *Compensation: *£40K - £55K, depending on experience (+ a performance-based annual bonus). *Employment Type:* Full-time, based at our office (with some work from home flexibility when necessary). *Job Location:* The Mill, Horton Road, Stanwell Moor, Surrey, TW19 6BJ, United Kingdom. *About Halewood Chemicals: *Halewood Chemicals is a producer & distributor of generic pharmaceuticals and raw materials. Based in the United Kingdom, we export all over the world. Founded as a wholesaler of medicines and raw materials, Halewood has since expanded into the development and licensing of own brand generic pharmaceutical finished products and over-the-counter (OTC) healthcare products. The Halewood Chemicals Group was formed by Dr Gordon James Pritchard in 1947. Over the past 70 years, the group has provided healthcare products to healthcare professionals all over the world - from small projects to national tenders. To this day it continues to be a family business, with Dr Pritchard's daughter, Mrs Susan de Zulueta, the current managing director.
CK Group are recruiting for Regulatory Affairs Manager to join a company in the Pharmaceutical industry at their site based in High Wycombe on a contract basis for 6 months. *Salary:* £58.91 per hour PAYE Depending on experience *Regulatory Affairs Manager Role:* * Prepares and submits regulatory documentation with support from RSMO as required * Responsible for the content of the local labelling documents released to prescribers and patients * Prepares and distributes local labelling documents within stipulated timelines following receipt of relevant approvals from RRR * Prepares and manages local procedures following EMEA Regulatory Affairs strategic plan, assuring timely execution and compliance * Partner with allocated CVT to provide RA expertise and support implements risk management plans and when required co-ordinates cross-functional team to implement/update Risk Management Educational Material *Your Background:* * Life Sciences or Chemistry graduate to honours level or equivalent. * Brexit related regulatory knowledge and experience. * Must have hands on experience in management of day to day UK regulatory procedures. *Company:* Our client is one of the world's leading research-based pharmaceutical companies and is part of a global family of companies. *Location:* This Regulatory Affairs Manager role will be based at our client's site in High Wycombe, Buckinghamshire although there could be flexibility for home working. *Apply:* Please quote reference 50185.
Apr 16, 2021
Full time
CK Group are recruiting for Regulatory Affairs Manager to join a company in the Pharmaceutical industry at their site based in High Wycombe on a contract basis for 6 months. *Salary:* £58.91 per hour PAYE Depending on experience *Regulatory Affairs Manager Role:* * Prepares and submits regulatory documentation with support from RSMO as required * Responsible for the content of the local labelling documents released to prescribers and patients * Prepares and distributes local labelling documents within stipulated timelines following receipt of relevant approvals from RRR * Prepares and manages local procedures following EMEA Regulatory Affairs strategic plan, assuring timely execution and compliance * Partner with allocated CVT to provide RA expertise and support implements risk management plans and when required co-ordinates cross-functional team to implement/update Risk Management Educational Material *Your Background:* * Life Sciences or Chemistry graduate to honours level or equivalent. * Brexit related regulatory knowledge and experience. * Must have hands on experience in management of day to day UK regulatory procedures. *Company:* Our client is one of the world's leading research-based pharmaceutical companies and is part of a global family of companies. *Location:* This Regulatory Affairs Manager role will be based at our client's site in High Wycombe, Buckinghamshire although there could be flexibility for home working. *Apply:* Please quote reference 50185.
PLEASE SUBMIT ENGLISH LANGUAGE RESUMES ONLY *Various Seniority Levels * Home-Based/Remote Based Contract Opportunity *Full Time (FTE 1.0) *6+ month duration Do you prefer flexible work options that allow you to work as a contractor, while also being immersed in the PPD Culture? Apply today to learn more about current and upcoming contractor opportunities through our Functional Service Partnership team. Functional Service Partnership Homepage: Position Summary Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services. *Qualifications:* Essential Functions * Supports the preparation of documentation and submissions under guidance. * Coordinates and manages client deliverables supporting regulatory compliance. * Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects. Assists with project budgeting/forecasting. * Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines. * Assists in business development and pricing of projects for the department. * Evaluates client needs in relationship to overall project timelines, quality and delivery. * Engages other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed. Education and Experience Required * Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). * In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities * Good English language (written and oral) communication skills as well as local language where applicable Good attention to detail and quality as well as editorial/proofreading skills * Good interpersonal skills to work effectively in a team environment * Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies * Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects * Good negotiation skills * Capable of working independently with direction and exercising independent judgment * Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables * Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management * Basic understanding of medical terminology, statistical concepts, and guidelines * Good analytical, investigative and problem-solving skills * Capable of interpreting data PPD is an inclusive equal employment opportunity company. We value all people regardless of background, experience and abilities. PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role * Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. * Able to work upright and stationary for typical working hours. * Ability to use and learn standard office equipment and technology with proficiency. * Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. * May require travel. (Recruiter will provide more details.)
Apr 16, 2021
Full time
PLEASE SUBMIT ENGLISH LANGUAGE RESUMES ONLY *Various Seniority Levels * Home-Based/Remote Based Contract Opportunity *Full Time (FTE 1.0) *6+ month duration Do you prefer flexible work options that allow you to work as a contractor, while also being immersed in the PPD Culture? Apply today to learn more about current and upcoming contractor opportunities through our Functional Service Partnership team. Functional Service Partnership Homepage: Position Summary Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services. *Qualifications:* Essential Functions * Supports the preparation of documentation and submissions under guidance. * Coordinates and manages client deliverables supporting regulatory compliance. * Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects. Assists with project budgeting/forecasting. * Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines. * Assists in business development and pricing of projects for the department. * Evaluates client needs in relationship to overall project timelines, quality and delivery. * Engages other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed. Education and Experience Required * Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). * In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities * Good English language (written and oral) communication skills as well as local language where applicable Good attention to detail and quality as well as editorial/proofreading skills * Good interpersonal skills to work effectively in a team environment * Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies * Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects * Good negotiation skills * Capable of working independently with direction and exercising independent judgment * Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables * Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management * Basic understanding of medical terminology, statistical concepts, and guidelines * Good analytical, investigative and problem-solving skills * Capable of interpreting data PPD is an inclusive equal employment opportunity company. We value all people regardless of background, experience and abilities. PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role * Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. * Able to work upright and stationary for typical working hours. * Ability to use and learn standard office equipment and technology with proficiency. * Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. * May require travel. (Recruiter will provide more details.)
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. If you're a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD is the place to be. Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment - and help get life-changing therapies to patients faster. As a Principal Regulatory Affairs Specialist for Chemistry, Manufacture and Controls (CMC) - lead focus on Advanced Therapies, you will provide innovative regulatory solutions to our clients. The purpose of this role is to lead and support Global Regulatory CMC projects across multiple product types with a lead focus on Advanced Therapies (Cell and Gene therapies). This role serves as the lead over several projects in providing innovative solutions including CMC regulatory expertise and client interface to provide strategic regulatory intelligence, and guidance supporting product development from preclinical through registration and product optimization. You will provide strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements and act as liaison with internal and external clients in the provision and marketing of these services. Essential functions of the role specifically include: • Application of strong regulatory experience in the area of ATMP - advanced therapy medicinal products (cell and gene therapy products) and biological/recombinant products. • Preparation of EU dossier applications for genetically modified organisms (GMO) • Authoring of GMO dossiers and associated regulatory documentation • Authoring of EU IMPD and US IND Module 3 for biologics, cell and gene therapies and small molecule product types • Authoring of EMA, FDA, Health Canada, National EU RA, UK MHRA, Scientific Advice and related meeting packages • Generation of responses to agency questions. • Client project interface and project management Additionally: • You will provide senior review of regulatory documents and submissions created within or outside of the company in order to ensure high quality standards that meet or exceed client expectations, local and regional requirements. • You will act as subject matter expert in providing regulatory strategy advice to internal and external clients on projects of moderate complexity. • Provide internal clients with up-to-date legislation and guidance as it becomes available. • Participate in project management activities to support the provision of regulatory services, and act as liaison with internal and external clients in the provision of marketing these services. • Provide matrix/project leadership, training and guidance to junior team members to support understanding of regulations, impact on study, assessment of risk, etc., and to achieve a specific goal and/or project deliverables. • May provide input on performance reviews to management. • Ensures adherence to project budgets, time schedules, and scope of work. • Ensures compliance with relevant organizational and regulatory SOPs and WPDs. • Contributes to business development activities, including project budgeting/forecasting. *Qualifications:* Ideally you will have: • Application of strong regulatory experience in the area of ATMP - advanced therapy medicinal products (cell and gene therapy products) and biological/recombinant products. • Preparation of EU dossier applications for genetically modified organisms (GMO) • Authoring of EU IMPD and US IND Module 3 for biologics, cell and gene therapies and small molecule product types • Authoring of Scientific Advice and related meeting packages • Generation of responses to agency questions. • Client project interface and project management Knowledge, Skills and Abilities: • Excellent English language (written and oral) communication skills as well as local language where applicable • Excellent attention to detail and quality as well as excellent editorial/proofreading skills • Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments • Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies • Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects • Excellent negotiation skills • Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables • Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines • Excellent analytical, investigative and problem-solving skills • Understanding of budgeting and forecasting At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel. - We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing -We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you. *LI-SH1 As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.
Apr 16, 2021
Full time
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. If you're a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD is the place to be. Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment - and help get life-changing therapies to patients faster. As a Principal Regulatory Affairs Specialist for Chemistry, Manufacture and Controls (CMC) - lead focus on Advanced Therapies, you will provide innovative regulatory solutions to our clients. The purpose of this role is to lead and support Global Regulatory CMC projects across multiple product types with a lead focus on Advanced Therapies (Cell and Gene therapies). This role serves as the lead over several projects in providing innovative solutions including CMC regulatory expertise and client interface to provide strategic regulatory intelligence, and guidance supporting product development from preclinical through registration and product optimization. You will provide strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements and act as liaison with internal and external clients in the provision and marketing of these services. Essential functions of the role specifically include: • Application of strong regulatory experience in the area of ATMP - advanced therapy medicinal products (cell and gene therapy products) and biological/recombinant products. • Preparation of EU dossier applications for genetically modified organisms (GMO) • Authoring of GMO dossiers and associated regulatory documentation • Authoring of EU IMPD and US IND Module 3 for biologics, cell and gene therapies and small molecule product types • Authoring of EMA, FDA, Health Canada, National EU RA, UK MHRA, Scientific Advice and related meeting packages • Generation of responses to agency questions. • Client project interface and project management Additionally: • You will provide senior review of regulatory documents and submissions created within or outside of the company in order to ensure high quality standards that meet or exceed client expectations, local and regional requirements. • You will act as subject matter expert in providing regulatory strategy advice to internal and external clients on projects of moderate complexity. • Provide internal clients with up-to-date legislation and guidance as it becomes available. • Participate in project management activities to support the provision of regulatory services, and act as liaison with internal and external clients in the provision of marketing these services. • Provide matrix/project leadership, training and guidance to junior team members to support understanding of regulations, impact on study, assessment of risk, etc., and to achieve a specific goal and/or project deliverables. • May provide input on performance reviews to management. • Ensures adherence to project budgets, time schedules, and scope of work. • Ensures compliance with relevant organizational and regulatory SOPs and WPDs. • Contributes to business development activities, including project budgeting/forecasting. *Qualifications:* Ideally you will have: • Application of strong regulatory experience in the area of ATMP - advanced therapy medicinal products (cell and gene therapy products) and biological/recombinant products. • Preparation of EU dossier applications for genetically modified organisms (GMO) • Authoring of EU IMPD and US IND Module 3 for biologics, cell and gene therapies and small molecule product types • Authoring of Scientific Advice and related meeting packages • Generation of responses to agency questions. • Client project interface and project management Knowledge, Skills and Abilities: • Excellent English language (written and oral) communication skills as well as local language where applicable • Excellent attention to detail and quality as well as excellent editorial/proofreading skills • Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments • Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies • Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects • Excellent negotiation skills • Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables • Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines • Excellent analytical, investigative and problem-solving skills • Understanding of budgeting and forecasting At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel. - We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing -We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you. *LI-SH1 As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.
Senior/Regulatory Affairs Manager - Client Dedicated (CMC - Small Molecules, Biologics) We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. PPD has an exciting opportunity for a Senior/Regulatory Affairs Manager to join us exclusively for one of our strategic partners. PPD works in collaboration with this pharmaceutical partner; you will be dedicated to the client projects, processes, working within their teams and systems on behalf of PPD. In this role you will be a pivotal team member with at least 5-7 years of regulatory experience, responsible for driving and leading regulatory CMC strategy. You will provide innovative solutions including global regulatory therapeutic area expertise, strategic regulatory intelligence and guidance for product development from preclinical through registration and product optimization. You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients in the provision of these services. *Qualifications:* The ideal candidate will have: - 5-7 years of relevant regulatory CMC experience - Small molecules and biologics expertise - Expertise in writing CMC sections of the dossier - Experience with scientific advice attendance and writing - Proven project management experience and success building relationships across a diverse stakeholder team Knowledge, Skills and Abilities: • Excellent interpersonal skills, and oral and written communication skills • Excellent organizational and planning skills • Good negotiation skills • Ability to work on own initiative • Good judgement and decision-making skills • Ability to act as liaison with other departments where necessary At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly values a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel. - We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing -We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you. *LI-SH1
Apr 16, 2021
Full time
Senior/Regulatory Affairs Manager - Client Dedicated (CMC - Small Molecules, Biologics) We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. PPD has an exciting opportunity for a Senior/Regulatory Affairs Manager to join us exclusively for one of our strategic partners. PPD works in collaboration with this pharmaceutical partner; you will be dedicated to the client projects, processes, working within their teams and systems on behalf of PPD. In this role you will be a pivotal team member with at least 5-7 years of regulatory experience, responsible for driving and leading regulatory CMC strategy. You will provide innovative solutions including global regulatory therapeutic area expertise, strategic regulatory intelligence and guidance for product development from preclinical through registration and product optimization. You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients in the provision of these services. *Qualifications:* The ideal candidate will have: - 5-7 years of relevant regulatory CMC experience - Small molecules and biologics expertise - Expertise in writing CMC sections of the dossier - Experience with scientific advice attendance and writing - Proven project management experience and success building relationships across a diverse stakeholder team Knowledge, Skills and Abilities: • Excellent interpersonal skills, and oral and written communication skills • Excellent organizational and planning skills • Good negotiation skills • Ability to work on own initiative • Good judgement and decision-making skills • Ability to act as liaison with other departments where necessary At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly values a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel. - We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing -We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you. *LI-SH1
Senior Regulatory Affairs Manager, Biopharma; Major Biologic Product, EU & Global & full Regulatory pipeline exposure - Top Biopharma. The role is focused on a Major Biologic Drug roll-out. Regulatory Strategy, Project Management, Clinical/Development Regulatory, Registrations and Life-cycle maintenance across European and International Markets. Fast-growing and successful Biopharma located in Central/West London!! Some flexible working offered. Regulatory Strategy and Project Leading - EU & Global in scope. Development; Product launches and roll-out. Are you a Regulatory Manager or Project Manager adept in Strategy and Global Development, Registrations and Life-cycle Management activity? If so, this is the opportunity you have been waiting for. This Senior Regulatory Affairs Manager role is for a fast-growing and highly successful Biopharma with a portfolio of 'cutting-edge' products; this role will be based in a desirable area in Central/West London. The role is focused on: Clinical/Development, Registrations and Post marketing/Life-cycle Management. Clinical, non-Clinical & CMC combination. Reporting to The Head of Regulatory Affairs, you will Project Lead & Advise on European & Global Regulatory Affairs Strategy and 'hands-on' activity. Product ownership of a recently approved major new drug. Technically, you will have good working knowledge and experience of CTA's and other Development Regulatory, New Registrations; CTD/Dossiers for MAA's; National Submissions/MRP, DCP and particularly Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's. PSUR's. Ideally, you will have participated in Scientific Advice meetings with Regulatory Authorities and PIP's/PIP Waivers. Orphan Drugs/Rare Diseases. You will collaborate closely with all other key Global Regulatory Affairs stakeholders, including other Global Regulatory Leads, Labelling, CMC, Regulatory Operations, other Regulatory Teams and Regulatory Affiliates, to ensure that all aspects of the European Strategy are observed and implemented. You will be adept in Regulatory Strategy & Tactics and have good experience in dealing with Affiliates. Ideally, you will have experience of taking Products from Late Phase, through to successful New Registrations and Post marketing. You will be required to interface with Commercial Teams and will operate as the primary interface with Affiliates across assigned Therapeutic Areas. You will possess good commercial awareness and an excellent eye for detail. Candidates from a Biopharma or Pharma background, in Global, European & International Regulatory Affairs and Project Management/Leadership with 5-10 year's solid experience should be suitable for this position. Superb organisation - a top employer with outstanding products and very desirable to have on your CV. A very competitive salary package is on offer for the right candidate. Desirable Central/West London location which is also convenient for those who live close to London in Berkshire, Surrey, and Buckinghamshire. Some Travel may be required in this role. If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner at Turner Regulatory Recruitment on /, or by clicking Apply Now.
Apr 16, 2021
Full time
Senior Regulatory Affairs Manager, Biopharma; Major Biologic Product, EU & Global & full Regulatory pipeline exposure - Top Biopharma. The role is focused on a Major Biologic Drug roll-out. Regulatory Strategy, Project Management, Clinical/Development Regulatory, Registrations and Life-cycle maintenance across European and International Markets. Fast-growing and successful Biopharma located in Central/West London!! Some flexible working offered. Regulatory Strategy and Project Leading - EU & Global in scope. Development; Product launches and roll-out. Are you a Regulatory Manager or Project Manager adept in Strategy and Global Development, Registrations and Life-cycle Management activity? If so, this is the opportunity you have been waiting for. This Senior Regulatory Affairs Manager role is for a fast-growing and highly successful Biopharma with a portfolio of 'cutting-edge' products; this role will be based in a desirable area in Central/West London. The role is focused on: Clinical/Development, Registrations and Post marketing/Life-cycle Management. Clinical, non-Clinical & CMC combination. Reporting to The Head of Regulatory Affairs, you will Project Lead & Advise on European & Global Regulatory Affairs Strategy and 'hands-on' activity. Product ownership of a recently approved major new drug. Technically, you will have good working knowledge and experience of CTA's and other Development Regulatory, New Registrations; CTD/Dossiers for MAA's; National Submissions/MRP, DCP and particularly Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's. PSUR's. Ideally, you will have participated in Scientific Advice meetings with Regulatory Authorities and PIP's/PIP Waivers. Orphan Drugs/Rare Diseases. You will collaborate closely with all other key Global Regulatory Affairs stakeholders, including other Global Regulatory Leads, Labelling, CMC, Regulatory Operations, other Regulatory Teams and Regulatory Affiliates, to ensure that all aspects of the European Strategy are observed and implemented. You will be adept in Regulatory Strategy & Tactics and have good experience in dealing with Affiliates. Ideally, you will have experience of taking Products from Late Phase, through to successful New Registrations and Post marketing. You will be required to interface with Commercial Teams and will operate as the primary interface with Affiliates across assigned Therapeutic Areas. You will possess good commercial awareness and an excellent eye for detail. Candidates from a Biopharma or Pharma background, in Global, European & International Regulatory Affairs and Project Management/Leadership with 5-10 year's solid experience should be suitable for this position. Superb organisation - a top employer with outstanding products and very desirable to have on your CV. A very competitive salary package is on offer for the right candidate. Desirable Central/West London location which is also convenient for those who live close to London in Berkshire, Surrey, and Buckinghamshire. Some Travel may be required in this role. If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner at Turner Regulatory Recruitment on /, or by clicking Apply Now.
CK Clinical are recruiting for an Associate Director, Regulatory Affairs to join Boyds Consultants. Boyds are a consultancy providing a wide range of expertise and skills central to the development of pharmaceutical and biotechnology medicinal products and medical devices. Working with early stage biotechs, medical device companies and universities, the team supports the development of advanced therapy medicinal products (ATMPs), small molecules and biologics across a wide range of therapeutic areas. This is a permanent position to join their award-winning Regulatory team. Remote working can be considered, with occasional visits to site in Cambridge or Crewe. *Responsibilities:* As Associate Director, Regulatory Affairs you will independently lead projects to develop, review and execute regulatory strategy for clients, and will also take the lead delivering regulatory activities/submissions necessary to support product development and registration. *Key duties will include:* - Providing expert strategic advice to clients, taking into account regulations and guidelines relevant to their products. - Preparation of regulatory submission documents including orphan drug designation applications, scientific advice briefing documents, CTA/INDs, paediatric investigation plans, PRIME/BTD and MAA/NDAs. - Lead regulatory agency interaction and negotiations. - Provide support to the wider business, potentially including mentoring and business development. - Be a leader in developing new procedures/processes for complex ATMPs. *Qualifications:* As Associate Director, Regulatory Affairs you will require: - At least a Life Sciences degree. - Proven Regulatory Affairs experience within the pharmaceutical industry and product development. Experience within consultancies is a bonus. - Experience working with ATMPs is essential. - Extensive experience leading the development of Regulatory Strategy. - Strong experience with EU and US submissions and regulations. - Ability to lead Health Authority interactions. - Self-starter attitude, with the ability to independently find creative solutions for complex problems. *Apply:* Entitlement to work in the UK is essential. Please quote reference 50069 in all correspondence. CLINBOYD
Apr 16, 2021
Full time
CK Clinical are recruiting for an Associate Director, Regulatory Affairs to join Boyds Consultants. Boyds are a consultancy providing a wide range of expertise and skills central to the development of pharmaceutical and biotechnology medicinal products and medical devices. Working with early stage biotechs, medical device companies and universities, the team supports the development of advanced therapy medicinal products (ATMPs), small molecules and biologics across a wide range of therapeutic areas. This is a permanent position to join their award-winning Regulatory team. Remote working can be considered, with occasional visits to site in Cambridge or Crewe. *Responsibilities:* As Associate Director, Regulatory Affairs you will independently lead projects to develop, review and execute regulatory strategy for clients, and will also take the lead delivering regulatory activities/submissions necessary to support product development and registration. *Key duties will include:* - Providing expert strategic advice to clients, taking into account regulations and guidelines relevant to their products. - Preparation of regulatory submission documents including orphan drug designation applications, scientific advice briefing documents, CTA/INDs, paediatric investigation plans, PRIME/BTD and MAA/NDAs. - Lead regulatory agency interaction and negotiations. - Provide support to the wider business, potentially including mentoring and business development. - Be a leader in developing new procedures/processes for complex ATMPs. *Qualifications:* As Associate Director, Regulatory Affairs you will require: - At least a Life Sciences degree. - Proven Regulatory Affairs experience within the pharmaceutical industry and product development. Experience within consultancies is a bonus. - Experience working with ATMPs is essential. - Extensive experience leading the development of Regulatory Strategy. - Strong experience with EU and US submissions and regulations. - Ability to lead Health Authority interactions. - Self-starter attitude, with the ability to independently find creative solutions for complex problems. *Apply:* Entitlement to work in the UK is essential. Please quote reference 50069 in all correspondence. CLINBOYD
Director, Regulatory Affairs - Biologics/ATMP/Gene Therapies. Global Regulatory Lead - EU and International. Point of contact with the Regulatory Authorities. Flexible working arrangements. This is a sensational Senior Regulatory role: this is a rare opportunity to join a fast-growing and dynamic Biopharma in a great location in Central London; superb role and a career-making challenge. Product Development in Phases I to III, Registrations and Post marketing activity. Advanced Therapies/Gene & Cell Therapies Product experience desirable. Rare Disease Products/Orphan Drugs. Europe and Global focus. Organise the Team within a Matrix-management environment. High-level Project Leading in addition to Line management of a small team - this role is a combination of Strategy, Development, MAA's, 'hands-on' and people management. This is a superb senior Regulatory opportunity with significant commercial possibilities. Experience in Advanced Therapies is ideal, along with General Biologics. High-Level Project Leadership skills are vital, along with a background of working knowledge and experience within Regulatory Affairs Strategy, Tactics & Implementation, throughout the Regulatory pipeline. This individual will be responsible for the Regulatory Strategy of several key products hence this is a very important hire. Geographical remit: Europe and International - knowledge of USA/FDA would be beneficial. Reporting to the VP of Regulatory Affairs, this position also operates as Project Leader with 'dotted-line reports. The candidate will possess an excellent understanding of 'how the industry works', is commercially astute, and have a good perception of how Regulatory issues can impact on profitability. There are several existing products in the pipeline hence the candidate's responsibilities will encompass taking the assigned products successfully through Late Phases through to successful BLA's/MAA's. The candidate will have expertise in Regulatory Strategy, Tactics and Implementation and have a deep understanding of Core Regulatory Affairs in Europe and Internationally. The geographic scope of this role is Pan-European, within the context of Global Regulatory Affairs. The candidate will possess full Regulatory pipeline experience, but with specific strengths in Clinical and Development Regulatory Affairs in Phases I to IV and MAA's/BLA's. Although there is a small team to manage, the company operates more on a matrix-management model hence the candidate must be prepared to be 'hands-on' and be heavily involved in the day-to-day leading of Projects. The candidate will need to have a substantial background in Development Regulatory, ideally: CTA's, IND's, IMPD's, IB's, Protocols, up-dates/amendments, and End of Trial Notifications - in conjunction with the management of CRO's. CTD/Dossiers for MAA's (overseeing all Modules 1-5); National Submissions/MRP, DCP, and particularly Centralised Procedure; Regulatory Strategy, Tactics, and Implementation; Regulatory Intelligence, Scientific Advice meetings with Regulatory Authorities. PIP's/Waivers and Orphan Drugs. A demonstrable working relationship with the major Regulatory Agencies and contacts within the EMA and other national Authorities would be an advantage in terms of company representation. The successful candidate will possess a substantial Regulatory Affairs background within Biologics and ideally ATMP Products of at least 8+ years. The candidate will demonstrate superb management and Project Leading skills along with mentoring of staff and the ability to develop and expand a team when necessary. This position is based Central London and requires travel as can be expected with a role of this seniority. Flexible working arrangements. A significant salary package is on offer for the right candidate, this will include a superb basic, LTI's, excellent bonus and numerous other benefits. If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner, at Turner Regulatory Recruitment, on / ; , or , or submit an application by clicking Apply Now.
Apr 16, 2021
Full time
Director, Regulatory Affairs - Biologics/ATMP/Gene Therapies. Global Regulatory Lead - EU and International. Point of contact with the Regulatory Authorities. Flexible working arrangements. This is a sensational Senior Regulatory role: this is a rare opportunity to join a fast-growing and dynamic Biopharma in a great location in Central London; superb role and a career-making challenge. Product Development in Phases I to III, Registrations and Post marketing activity. Advanced Therapies/Gene & Cell Therapies Product experience desirable. Rare Disease Products/Orphan Drugs. Europe and Global focus. Organise the Team within a Matrix-management environment. High-level Project Leading in addition to Line management of a small team - this role is a combination of Strategy, Development, MAA's, 'hands-on' and people management. This is a superb senior Regulatory opportunity with significant commercial possibilities. Experience in Advanced Therapies is ideal, along with General Biologics. High-Level Project Leadership skills are vital, along with a background of working knowledge and experience within Regulatory Affairs Strategy, Tactics & Implementation, throughout the Regulatory pipeline. This individual will be responsible for the Regulatory Strategy of several key products hence this is a very important hire. Geographical remit: Europe and International - knowledge of USA/FDA would be beneficial. Reporting to the VP of Regulatory Affairs, this position also operates as Project Leader with 'dotted-line reports. The candidate will possess an excellent understanding of 'how the industry works', is commercially astute, and have a good perception of how Regulatory issues can impact on profitability. There are several existing products in the pipeline hence the candidate's responsibilities will encompass taking the assigned products successfully through Late Phases through to successful BLA's/MAA's. The candidate will have expertise in Regulatory Strategy, Tactics and Implementation and have a deep understanding of Core Regulatory Affairs in Europe and Internationally. The geographic scope of this role is Pan-European, within the context of Global Regulatory Affairs. The candidate will possess full Regulatory pipeline experience, but with specific strengths in Clinical and Development Regulatory Affairs in Phases I to IV and MAA's/BLA's. Although there is a small team to manage, the company operates more on a matrix-management model hence the candidate must be prepared to be 'hands-on' and be heavily involved in the day-to-day leading of Projects. The candidate will need to have a substantial background in Development Regulatory, ideally: CTA's, IND's, IMPD's, IB's, Protocols, up-dates/amendments, and End of Trial Notifications - in conjunction with the management of CRO's. CTD/Dossiers for MAA's (overseeing all Modules 1-5); National Submissions/MRP, DCP, and particularly Centralised Procedure; Regulatory Strategy, Tactics, and Implementation; Regulatory Intelligence, Scientific Advice meetings with Regulatory Authorities. PIP's/Waivers and Orphan Drugs. A demonstrable working relationship with the major Regulatory Agencies and contacts within the EMA and other national Authorities would be an advantage in terms of company representation. The successful candidate will possess a substantial Regulatory Affairs background within Biologics and ideally ATMP Products of at least 8+ years. The candidate will demonstrate superb management and Project Leading skills along with mentoring of staff and the ability to develop and expand a team when necessary. This position is based Central London and requires travel as can be expected with a role of this seniority. Flexible working arrangements. A significant salary package is on offer for the right candidate, this will include a superb basic, LTI's, excellent bonus and numerous other benefits. If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner, at Turner Regulatory Recruitment, on / ; , or , or submit an application by clicking Apply Now.
CK Group are recruiting for a Regulatory Operations Manager to join a small, exciting pharmaceutical company specialising in rare diseases on a permanent basis. This Regulatory Operations Manager role can be remote in the UK. *The Role:* This Regulatory Operations Manager is to lead the set-up and development of the Regulatory Operations space. This will include developing regulatory publishing strategy; evaluating, choosing and implementing new regulatory systems; and being the Regulatory Operations expert within the company. *Regulatory Operations Manager responsibilities:* - Oversee the development and maintenance of processes, templates, standards, and guide sheets for submissions. - Independently format, publish, transmit and archive all submission types. - Track submission statuses and management timelines. - Oversee applications and systems support, systems training programs, and supporting development projects within Regulatory Affairs. - Stay updated of new guidance released by health agencies and implementing changes where needed. *Your Background:* - At least a University degree in a scientific discipline. - Proven Regulatory Affairs experience within pharma. - Strong experience independently managing and publishing of major regulatory submissions for investigational or marketed products to global health authorities in eCTD format. - Proven knowledge of global health authority regulations. - Technical experience in handling eCTD Publishing tools and Submission portals is required. *Apply:* Entitlement to work in the UK is essential. Please quote reference 49814 in all correspondence.
Apr 16, 2021
Full time
CK Group are recruiting for a Regulatory Operations Manager to join a small, exciting pharmaceutical company specialising in rare diseases on a permanent basis. This Regulatory Operations Manager role can be remote in the UK. *The Role:* This Regulatory Operations Manager is to lead the set-up and development of the Regulatory Operations space. This will include developing regulatory publishing strategy; evaluating, choosing and implementing new regulatory systems; and being the Regulatory Operations expert within the company. *Regulatory Operations Manager responsibilities:* - Oversee the development and maintenance of processes, templates, standards, and guide sheets for submissions. - Independently format, publish, transmit and archive all submission types. - Track submission statuses and management timelines. - Oversee applications and systems support, systems training programs, and supporting development projects within Regulatory Affairs. - Stay updated of new guidance released by health agencies and implementing changes where needed. *Your Background:* - At least a University degree in a scientific discipline. - Proven Regulatory Affairs experience within pharma. - Strong experience independently managing and publishing of major regulatory submissions for investigational or marketed products to global health authorities in eCTD format. - Proven knowledge of global health authority regulations. - Technical experience in handling eCTD Publishing tools and Submission portals is required. *Apply:* Entitlement to work in the UK is essential. Please quote reference 49814 in all correspondence.
CK Group are recruiting for a Senior Manager, International Regulatory Affairs to join a biotechnology company home based on a permanent basis. *Senior Manager, International Regulatory Affairs Role:* The Senior Regulatory Manager is responsible for worldwide registrations and regulatory compliance throughout the lifecycle management of these marketing authorizations, under the oversight of the Global Head of Regulatory Affairs and Compliance and in collaboration with other Corporate functions as needed. *Key responsibilities will include:* - Definition and implementation of regulatory strategies, organization and planning of regulatory affairs activities. - Leading or co-leading the preparation and filing of both first registration and post-approval packages, in alignment with internal functions (CMC, clinical, etc.) as well as external partners in International markets. - Follow-up of applications for marketing authorization, answers to questions from regulatory authorities and compilation of necessary supplements. - Drafting, follow-up and/or review of post approval applications (renewals, variations) to ensure the maintenance of marketing authorisations. - Supporting product launch, tenders, and interface with distributors on regulatory aspects. *Your Background:* - Higher degree (M.Sc; Pharm.D or PhD) in Pharmacy or Life Sciences. - Minimum 8 years of experience in a similar role at international level, preferably in SMEs and/or in a consultancy role. - Substantial experience in obtaining and maintaining product licenses worldwide, particularly in International Markets; of particular interest APAC and LATAM regions. - Solid knowledge of regulations at European and international level. - Cross-functional leadership, strategic vision and negotiation skills. *Apply:* Entitlement to work in the UK is essential. Please quote reference 49813.
Apr 16, 2021
Full time
CK Group are recruiting for a Senior Manager, International Regulatory Affairs to join a biotechnology company home based on a permanent basis. *Senior Manager, International Regulatory Affairs Role:* The Senior Regulatory Manager is responsible for worldwide registrations and regulatory compliance throughout the lifecycle management of these marketing authorizations, under the oversight of the Global Head of Regulatory Affairs and Compliance and in collaboration with other Corporate functions as needed. *Key responsibilities will include:* - Definition and implementation of regulatory strategies, organization and planning of regulatory affairs activities. - Leading or co-leading the preparation and filing of both first registration and post-approval packages, in alignment with internal functions (CMC, clinical, etc.) as well as external partners in International markets. - Follow-up of applications for marketing authorization, answers to questions from regulatory authorities and compilation of necessary supplements. - Drafting, follow-up and/or review of post approval applications (renewals, variations) to ensure the maintenance of marketing authorisations. - Supporting product launch, tenders, and interface with distributors on regulatory aspects. *Your Background:* - Higher degree (M.Sc; Pharm.D or PhD) in Pharmacy or Life Sciences. - Minimum 8 years of experience in a similar role at international level, preferably in SMEs and/or in a consultancy role. - Substantial experience in obtaining and maintaining product licenses worldwide, particularly in International Markets; of particular interest APAC and LATAM regions. - Solid knowledge of regulations at European and international level. - Cross-functional leadership, strategic vision and negotiation skills. *Apply:* Entitlement to work in the UK is essential. Please quote reference 49813.
Due to our ongoing global expansion, PRA are hiring a Global Start Up & Regulatory Affairs Lead to join our growing Global Regulatory Clinical Services team in APAC. This is a sponsor facing position focusing on start-up activities. You will responsible for coordinating all Central Independent Ethics Committee (IEC), Regulatory Agency (RA) and other central authority submissions to ensure contractual timelines are met. This is role is open to locations across APAC with flexibility to be home or office based. *Why apply?* * You will take ownership of managing Regulatory Affairs projects during the start-up of clinical trials globally including the APAC region, EU and Latin America, this will allow you to expand you knowledge and become an expert on regions outside of your own * Responsible for the ensuring efficient start-up process on assigned studies, focusing on all EC and IRB submissions and acting as main contact with authorities * You will be the direct point of contact for the sponsor enabling you to foster strong and supportive relationships with clients and provide a consultative approach and practical solutions to any specific issues * Joining a team of 8, you will be part of a high-performing culture with access to career development and progression opportunities and be supported by management that encourages internal development * Location is not a restriction to talent and is open to many countries across APAC, there is also flexibility to be home of office based in this role depending on your preference * PRA are committed to providing career development pathways to you and provide ongoing support and training to enable you to exceed your career goals *Requirements* * This role is suited to a talented communicator who enjoys relationship building, managing sponsor interaction and taking a lead on projects * Previous clinical trials Start Up experience and a strong knowledge of current ICH and local Regulatory Agency and Ethics Committee regulations and understanding of regional guidelines * Fluency in spoken and written business English is essential and an additional language is highly desired * Previous experience working within CRO is required *Why PRA?* PRA is proud to be one of the consistent leaders in the CRO industry globally, employing over 18,000 people across 90 countries. We are committed to the future of clinical development & dedicated to helping our clients improve patient's lives through our partnering with new and innovative pharmaceutical and biotech companies. We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA. PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
Apr 16, 2021
Full time
Due to our ongoing global expansion, PRA are hiring a Global Start Up & Regulatory Affairs Lead to join our growing Global Regulatory Clinical Services team in APAC. This is a sponsor facing position focusing on start-up activities. You will responsible for coordinating all Central Independent Ethics Committee (IEC), Regulatory Agency (RA) and other central authority submissions to ensure contractual timelines are met. This is role is open to locations across APAC with flexibility to be home or office based. *Why apply?* * You will take ownership of managing Regulatory Affairs projects during the start-up of clinical trials globally including the APAC region, EU and Latin America, this will allow you to expand you knowledge and become an expert on regions outside of your own * Responsible for the ensuring efficient start-up process on assigned studies, focusing on all EC and IRB submissions and acting as main contact with authorities * You will be the direct point of contact for the sponsor enabling you to foster strong and supportive relationships with clients and provide a consultative approach and practical solutions to any specific issues * Joining a team of 8, you will be part of a high-performing culture with access to career development and progression opportunities and be supported by management that encourages internal development * Location is not a restriction to talent and is open to many countries across APAC, there is also flexibility to be home of office based in this role depending on your preference * PRA are committed to providing career development pathways to you and provide ongoing support and training to enable you to exceed your career goals *Requirements* * This role is suited to a talented communicator who enjoys relationship building, managing sponsor interaction and taking a lead on projects * Previous clinical trials Start Up experience and a strong knowledge of current ICH and local Regulatory Agency and Ethics Committee regulations and understanding of regional guidelines * Fluency in spoken and written business English is essential and an additional language is highly desired * Previous experience working within CRO is required *Why PRA?* PRA is proud to be one of the consistent leaders in the CRO industry globally, employing over 18,000 people across 90 countries. We are committed to the future of clinical development & dedicated to helping our clients improve patient's lives through our partnering with new and innovative pharmaceutical and biotech companies. We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA. PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
Hobson Prior currently have an exciting permanent opportunity for a Regulatory Affairs Manager to join a global leader within health and wellness. This position can be in either London or Tring with 1-2 working from home however please note that to be considered for this role you must have the right to work in this location. *Job Responsibilities*: * Accountable for all aspects of in market regulatory compliance for defined projects, brands and/ or portfolio including, but not limited to, new and existing products, packaging and communications. * Ensuring regulatory operations are adequately briefed & resource is secured for all projects. * Supports innovation/ new product development and renovation of existing products through, amongst others, review of product ideations; formula and raw material compliance review and assessment; development of new and review of existing claims: label development, review and approval; sales and marketing collateral including advertising, point of sale and web copy; registrations or licencing applications. * Provide training and support on regional/franchise/subject matter specialities to operations team to ensure effective compliant delivery of all operational tasks. * Ensures change controls are reviewed, approved and implemented within required timelines to maintain compliance. * Demonstrates expert understanding of all applicable Regulations, guidance and industry best practice and partners with internal stakeholders proactively to create and implement strategies to comply. * Manages Regulatory Agency and submissions, as required e.g. FDA 30 Day Notification Letters. * Horizon scanning: Monitor the industry landscape with a particular focus on new regulations and relevant litigation. * Follows Safety, Health, and Environmental policies and procedures. * Provides leadership and training to direct reports and peers, as relevant and when required, and works to maximise their skills and potential. * Other projects and duties as required/assigned. *Key Skills: * * Pro-active, creative, forward-thinker with the ability to think innovatively about integrated strategies for regulatory affairs while accurately anticipating future consequences and trends. * In an environment where developing and introducing new products quickly and effectively is a key driver of competitive advantage. * Acts to surpass goals, seizing opportunities to push the envelope. Communicates direction or changes with clear rationale and appeal. Advocates for the new direction, and takes it onboard personally, even countering conventional practice. * Create Possibilities From New Thinking, Generate Disruptive Change, Lead Change. *Requirements*: * Minimum of 5+ years' experience in a regulatory affairs role. * Solid understanding of the consumer healthcare/nutraceutical industry landscape and market trends. * Proven ability to build regulatory processes and systems. Quality experience/background is a plus. * Strong track record and technically savvy in the Regulatory Affairs function, able to provide expertise and guidance on product submissions with global health authorities. * Experience working with R&D and cross-functional teams desired. * Bachelor degree required; Advanced degree desirable. *Apply now*: If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page. Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
Apr 16, 2021
Full time
Hobson Prior currently have an exciting permanent opportunity for a Regulatory Affairs Manager to join a global leader within health and wellness. This position can be in either London or Tring with 1-2 working from home however please note that to be considered for this role you must have the right to work in this location. *Job Responsibilities*: * Accountable for all aspects of in market regulatory compliance for defined projects, brands and/ or portfolio including, but not limited to, new and existing products, packaging and communications. * Ensuring regulatory operations are adequately briefed & resource is secured for all projects. * Supports innovation/ new product development and renovation of existing products through, amongst others, review of product ideations; formula and raw material compliance review and assessment; development of new and review of existing claims: label development, review and approval; sales and marketing collateral including advertising, point of sale and web copy; registrations or licencing applications. * Provide training and support on regional/franchise/subject matter specialities to operations team to ensure effective compliant delivery of all operational tasks. * Ensures change controls are reviewed, approved and implemented within required timelines to maintain compliance. * Demonstrates expert understanding of all applicable Regulations, guidance and industry best practice and partners with internal stakeholders proactively to create and implement strategies to comply. * Manages Regulatory Agency and submissions, as required e.g. FDA 30 Day Notification Letters. * Horizon scanning: Monitor the industry landscape with a particular focus on new regulations and relevant litigation. * Follows Safety, Health, and Environmental policies and procedures. * Provides leadership and training to direct reports and peers, as relevant and when required, and works to maximise their skills and potential. * Other projects and duties as required/assigned. *Key Skills: * * Pro-active, creative, forward-thinker with the ability to think innovatively about integrated strategies for regulatory affairs while accurately anticipating future consequences and trends. * In an environment where developing and introducing new products quickly and effectively is a key driver of competitive advantage. * Acts to surpass goals, seizing opportunities to push the envelope. Communicates direction or changes with clear rationale and appeal. Advocates for the new direction, and takes it onboard personally, even countering conventional practice. * Create Possibilities From New Thinking, Generate Disruptive Change, Lead Change. *Requirements*: * Minimum of 5+ years' experience in a regulatory affairs role. * Solid understanding of the consumer healthcare/nutraceutical industry landscape and market trends. * Proven ability to build regulatory processes and systems. Quality experience/background is a plus. * Strong track record and technically savvy in the Regulatory Affairs function, able to provide expertise and guidance on product submissions with global health authorities. * Experience working with R&D and cross-functional teams desired. * Bachelor degree required; Advanced degree desirable. *Apply now*: If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page. Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
A pharmaceutical business seeks a new Head of Regulatory Affairs with experience in the Generic drug market to lead the Regulatory Affairs function and provide strategic input into all related activities. There is a broad portfolio across various therapeutic areas, with a busy pipeline and constant investment in their growth plans. This means lots of strategic input from the Head of Regulatory to ensure the best procedures and route to market, working with internal teams and external agents, contractors and affiliates. *Key Elements of the Role:* * Strategic Input- provide strategic regulatory coordination for all product development, ensuring compliance with relevant UK and EU legislation and guidelines to ensure successful product launches, while maintaining an existing portfolio of products. * Team Management- Creating and supporting development plans with each team member, giving them the tools to succeed in their roles * Compliance- ensures that Regulatory meets legal and compliance requirements, ethical standards and SOPs. * Broader Leadership- collaboration with all external stakeholders and internal business disciplines to facilitate successful growth *Essential Qualifications/Skills:* * Scientific Degree or equivalent business experience in the Generics market * Extensive knowledge of the regulatory environment and the impact of current issues. * Extensive knowledge of relevant UK and EU legislation procedures and guidelines. * Strong interpersonal skills at all levels, including people management, leadership, and stakeholder interaction * Experience in leading a successful team. * Ability to successfully manage numerous and complex projects concurrently * Can create strong working relationships with internal and external stakeholders This is a small and friendly company, who work in a nimble, collaborative way to bring a range of products to patients across various therapeutic areas- with ongoing new product pipeline ensuring variety and regular new challenges. The office is in South West London, but 50/50 WFH will be the norm post-COVID. Please apply today to be considered or contact Katie Dunbar on (0) or for more information.
Apr 16, 2021
Full time
A pharmaceutical business seeks a new Head of Regulatory Affairs with experience in the Generic drug market to lead the Regulatory Affairs function and provide strategic input into all related activities. There is a broad portfolio across various therapeutic areas, with a busy pipeline and constant investment in their growth plans. This means lots of strategic input from the Head of Regulatory to ensure the best procedures and route to market, working with internal teams and external agents, contractors and affiliates. *Key Elements of the Role:* * Strategic Input- provide strategic regulatory coordination for all product development, ensuring compliance with relevant UK and EU legislation and guidelines to ensure successful product launches, while maintaining an existing portfolio of products. * Team Management- Creating and supporting development plans with each team member, giving them the tools to succeed in their roles * Compliance- ensures that Regulatory meets legal and compliance requirements, ethical standards and SOPs. * Broader Leadership- collaboration with all external stakeholders and internal business disciplines to facilitate successful growth *Essential Qualifications/Skills:* * Scientific Degree or equivalent business experience in the Generics market * Extensive knowledge of the regulatory environment and the impact of current issues. * Extensive knowledge of relevant UK and EU legislation procedures and guidelines. * Strong interpersonal skills at all levels, including people management, leadership, and stakeholder interaction * Experience in leading a successful team. * Ability to successfully manage numerous and complex projects concurrently * Can create strong working relationships with internal and external stakeholders This is a small and friendly company, who work in a nimble, collaborative way to bring a range of products to patients across various therapeutic areas- with ongoing new product pipeline ensuring variety and regular new challenges. The office is in South West London, but 50/50 WFH will be the norm post-COVID. Please apply today to be considered or contact Katie Dunbar on (0) or for more information.
Job Title: Regulatory Affairs Manager Location: Oxford, Reading, London, Home-based Salary: £65,000 - £80,000 (negotiable DOE) My client is a specialist biotech within the infectious disease space who are now looking for a Regulatory Affairs Manager who can support with a global roll out of there pioneering COVID Testing technology. This role requires a candidate with a broad regulatory background within medical devices who will be able to lead on submissions, registration, health authority interactions as well as inputting into product development. Role: * Responsibility for preparation and submissions of regulatory applications and registrations * Review of promotional material * Point of contact for competent authorities (UKAS, MHRA, EMA) * Work across both Regulatory and Quality functions * License maintenance Experience: * 4 plus years within regulatory affairs * Broad experience with experience in at least one of the following: CE Marketing, UKAS, MHRA/EMA/FDA compliance, MDR compliance, IVDR compliance, CER * Able to work in a past paced environment This is an urgent hire for the business so if you are interested please apply with your updated CV and I will be in touch ASAP to discuss further.
Apr 16, 2021
Full time
Job Title: Regulatory Affairs Manager Location: Oxford, Reading, London, Home-based Salary: £65,000 - £80,000 (negotiable DOE) My client is a specialist biotech within the infectious disease space who are now looking for a Regulatory Affairs Manager who can support with a global roll out of there pioneering COVID Testing technology. This role requires a candidate with a broad regulatory background within medical devices who will be able to lead on submissions, registration, health authority interactions as well as inputting into product development. Role: * Responsibility for preparation and submissions of regulatory applications and registrations * Review of promotional material * Point of contact for competent authorities (UKAS, MHRA, EMA) * Work across both Regulatory and Quality functions * License maintenance Experience: * 4 plus years within regulatory affairs * Broad experience with experience in at least one of the following: CE Marketing, UKAS, MHRA/EMA/FDA compliance, MDR compliance, IVDR compliance, CER * Able to work in a past paced environment This is an urgent hire for the business so if you are interested please apply with your updated CV and I will be in touch ASAP to discuss further.
Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on.. At AstraZeneca work with diverse minds, all united by a shared passion to learn, grow and discover. Within *Oncology Regulatory Science and Strategy (ORSS)* we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. The *Senior Regulatory Affairs Director (SRAD)* serves as the *Franchise Global Regulatory Lead* *(GRL)* on *complex programs with multiple indications*. You will *lead the development and implementation of the global regulatory strategy for a product/group of products of increasing complexity*. In addition to GRL responsibilities, the SRAD has the ability to function in dual capacity by also serving as a regional lead based on their location. You will ensure that the strategy is designed to deliver rapid approval with competitive labelling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. You'll provide *team leadership and participate in coaching, and mentorship* to members of the large Global Regulatory Strategy Team and will be responsible for delivery globally to contribute to the global project team's deliverables. The SRAD establishes external relationships with key regulatory stakeholders, leveraging these to maintain competitive advantage. You will be viewed as a senior leader within the regulatory community. *Typical Accountabilities, what you will be doing:* * Accountable for leading the development and implementation of the global regulatory strategy for a product/group of products of increasing complexity or spanning multiple indications. This includes providing Regulatory leadership on franchise products with multiple indications and development programs. May also serve as a regional Regulatory Affairs Director (RAD) depending on location. * Ensure that the strategy is designed to deliver rapid approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. * Lead a Global Regulatory Strategy Team (GRST) of other GRLs responsible for specific indications/programs within the franchise, key contributing members from the regions, emerging markets, RA CMC, Labelling and members of the submission and execution team. Participate in coaching, and performance feedback to members of your GRST. * Lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities. * Represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic regulatory advice and accountable for all Regulatory activities * Accountable for the delivery of all regulatory milestones on your team including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations. You will lead preparation of the regulatory strategy document and target product labelling. * Demonstrate strategic leadership skills thereby contributing to effective product development. * Participate in and promote novel regulatory initiatives internally, and engage externally on the corresponding topics as needed. Lead the development of novel regulatory tools and technology. * Ensure appropriate planning and construction of the global dossier and core prescribing information led by the respective teams. Accountable for product maintenance, supply and compliance activities associated with marketed brands. * Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance. *Education, Qualifications, Skills and Experience:* *Essential:* * An advanced degree in a science related field and/or other appropriate knowledge/experience. * Previous demonstrated experience of regulatory drug development including product approval/launch. Successful leadership to at least one major regulatory approval at a global level including leading response team and labeling negotiations is desired. * Previous experience in leading major health authority interactions. * Solid knowledge of regulatory affairs within several therapeutic areas in early and late development. * Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Experience in relevant therapy area (small molecules & biologics) is preferred. * Proven leadership experience. * Ability to think strategically and critically and evaluate risks to regulatory activities. * Deep understanding of global regulatory science and will integrate with project strategy. You have a long standing experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs. *Desirable:* * Previous experience with FDA advisory committee and EMA oral explanation would be a plus * Previous experience working on due diligence activities and in a business alliance environment. * Ability to work strategically within a complex, business critical and high-profile development program. *Location:* Cambridge, UK *Salary:* Competitive + Excellent Benefits *Closing Date:* 30th April 2021 Next steps, if the role looks suitable to you please apply! *Where can I find out more?* Our Social Media, Follow AstraZeneca on LinkedIn []() Follow AstraZeneca on Facebook []() Follow AstraZeneca on Instagram []()
Apr 16, 2021
Full time
Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on.. At AstraZeneca work with diverse minds, all united by a shared passion to learn, grow and discover. Within *Oncology Regulatory Science and Strategy (ORSS)* we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. The *Senior Regulatory Affairs Director (SRAD)* serves as the *Franchise Global Regulatory Lead* *(GRL)* on *complex programs with multiple indications*. You will *lead the development and implementation of the global regulatory strategy for a product/group of products of increasing complexity*. In addition to GRL responsibilities, the SRAD has the ability to function in dual capacity by also serving as a regional lead based on their location. You will ensure that the strategy is designed to deliver rapid approval with competitive labelling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. You'll provide *team leadership and participate in coaching, and mentorship* to members of the large Global Regulatory Strategy Team and will be responsible for delivery globally to contribute to the global project team's deliverables. The SRAD establishes external relationships with key regulatory stakeholders, leveraging these to maintain competitive advantage. You will be viewed as a senior leader within the regulatory community. *Typical Accountabilities, what you will be doing:* * Accountable for leading the development and implementation of the global regulatory strategy for a product/group of products of increasing complexity or spanning multiple indications. This includes providing Regulatory leadership on franchise products with multiple indications and development programs. May also serve as a regional Regulatory Affairs Director (RAD) depending on location. * Ensure that the strategy is designed to deliver rapid approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. * Lead a Global Regulatory Strategy Team (GRST) of other GRLs responsible for specific indications/programs within the franchise, key contributing members from the regions, emerging markets, RA CMC, Labelling and members of the submission and execution team. Participate in coaching, and performance feedback to members of your GRST. * Lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities. * Represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic regulatory advice and accountable for all Regulatory activities * Accountable for the delivery of all regulatory milestones on your team including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations. You will lead preparation of the regulatory strategy document and target product labelling. * Demonstrate strategic leadership skills thereby contributing to effective product development. * Participate in and promote novel regulatory initiatives internally, and engage externally on the corresponding topics as needed. Lead the development of novel regulatory tools and technology. * Ensure appropriate planning and construction of the global dossier and core prescribing information led by the respective teams. Accountable for product maintenance, supply and compliance activities associated with marketed brands. * Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance. *Education, Qualifications, Skills and Experience:* *Essential:* * An advanced degree in a science related field and/or other appropriate knowledge/experience. * Previous demonstrated experience of regulatory drug development including product approval/launch. Successful leadership to at least one major regulatory approval at a global level including leading response team and labeling negotiations is desired. * Previous experience in leading major health authority interactions. * Solid knowledge of regulatory affairs within several therapeutic areas in early and late development. * Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Experience in relevant therapy area (small molecules & biologics) is preferred. * Proven leadership experience. * Ability to think strategically and critically and evaluate risks to regulatory activities. * Deep understanding of global regulatory science and will integrate with project strategy. You have a long standing experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs. *Desirable:* * Previous experience with FDA advisory committee and EMA oral explanation would be a plus * Previous experience working on due diligence activities and in a business alliance environment. * Ability to work strategically within a complex, business critical and high-profile development program. *Location:* Cambridge, UK *Salary:* Competitive + Excellent Benefits *Closing Date:* 30th April 2021 Next steps, if the role looks suitable to you please apply! *Where can I find out more?* Our Social Media, Follow AstraZeneca on LinkedIn []() Follow AstraZeneca on Facebook []() Follow AstraZeneca on Instagram []()
Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on... At AstraZeneca work with diverse minds, all united by a shared passion to learn, grow and discover. Within *Oncology Regulatory Science and Strategy (ORSS)* we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. *The Regulatory Affairs Director (RAD)* provides *strategic and operational regulatory leadership to the development, commercialisation and life cycle management of assigned product(s)*. You will serve as the *global regulatory lead (GRL) on early stage projects or specific indications of larger programs, or as regional regulatory lead*. You'll contribute significantly to overall product and clinical strategy. The role plays a key role *influencing regulatory authorities* through regular contacts to improve regulatory outcomes. The RAD *leads cross-functional teams in major regulatory submissions (NDA, IND/CTA)*, *health authority interactions, label discussions, and securing NDA/BLA approvals.* As a GRL, the RAD leads the Global Regulatory Strategy Team (GRST) in formulating Global Regulatory strategy and delivering on NDA Filings and Approvals. Alternatively, as a regional regulatory lead, the RAD is a member of the GRST and is accountable for providing the region-specific Regulatory strategy and advice. The RAD serves as the face of the company with health authorities. *Typical Accountabilities, what you will be doing:* * Accountable for leading the development and implementation of the regional or global regulatory strategy for a product/group of products. Ensures that the strategy is designed to deliver rapid approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. This includes health authority engagement strategy and considerations of expedited regulatory programs. * Lead cross-functional Teams in major health authority interactions. This includes setting the strategy and planning for the interaction, driving the formulation of the briefing document focused on strategy and scientific content, leading the team through meetings rehearsals, and moderating the meeting itself. * Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labelling and members of the submission and execution team. Participate in coaching, and performance feedback to members of your GRST. * May (depending on role and project) represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic Regulatory advice and be accountable for all Regulatory activities * Accountable for the delivery of all regulatory milestones on your team including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations. Lead preparation of the regulatory strategy document and target product labeling. * Demonstrate strategic leadership skills contributing to effective product development. Provide team leadership and participate in coaching, and performance feedback to members of the GRST. * Accountable for initiating and delivering key regulatory documents and plans and leading the negotiations with health authorities. * Lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities. * Ensures appropriate planning and construction of the global dossier and core prescribing information led by the respective teams. Accountable for product maintenance, supply and compliance activities associated with marketed brands. * Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance. *Education, Qualifications, Skills and Experience:* *Essential:* * An advanced degree in a science related field and/or other appropriate knowledge/experience. * Previous demonstrated experience of regulatory drug development or equivalent, and experience with major Health Authority interactions. Prior experience with phase 3 design including end of phase 2 health authority interactions is desired. Contribution to a regulatory approval including leading response team and labelling negotiations would be a plus. * A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development. * Demonstrated competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills. * The ability to think strategically and critically and evaluate risks to regulatory activities. *Desirable:* * A good understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design. * Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Experience in relevant therapy area (small molecules & biologics) is preferred. * Ability to work strategically within a complex, business critical and high-profile development program. * Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical components *Location:* Cambridge, UK *Salary:* Competitive + Excellent Benefits *Closing Date:* 30th April 2021 Next steps, if the role looks suitable to you please apply! *Where can I find out more?* Our Social Media, Follow AstraZeneca on LinkedIn []() Follow AstraZeneca on Facebook []() Follow AstraZeneca on Instagram []()
Apr 16, 2021
Full time
Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on... At AstraZeneca work with diverse minds, all united by a shared passion to learn, grow and discover. Within *Oncology Regulatory Science and Strategy (ORSS)* we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. *The Regulatory Affairs Director (RAD)* provides *strategic and operational regulatory leadership to the development, commercialisation and life cycle management of assigned product(s)*. You will serve as the *global regulatory lead (GRL) on early stage projects or specific indications of larger programs, or as regional regulatory lead*. You'll contribute significantly to overall product and clinical strategy. The role plays a key role *influencing regulatory authorities* through regular contacts to improve regulatory outcomes. The RAD *leads cross-functional teams in major regulatory submissions (NDA, IND/CTA)*, *health authority interactions, label discussions, and securing NDA/BLA approvals.* As a GRL, the RAD leads the Global Regulatory Strategy Team (GRST) in formulating Global Regulatory strategy and delivering on NDA Filings and Approvals. Alternatively, as a regional regulatory lead, the RAD is a member of the GRST and is accountable for providing the region-specific Regulatory strategy and advice. The RAD serves as the face of the company with health authorities. *Typical Accountabilities, what you will be doing:* * Accountable for leading the development and implementation of the regional or global regulatory strategy for a product/group of products. Ensures that the strategy is designed to deliver rapid approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. This includes health authority engagement strategy and considerations of expedited regulatory programs. * Lead cross-functional Teams in major health authority interactions. This includes setting the strategy and planning for the interaction, driving the formulation of the briefing document focused on strategy and scientific content, leading the team through meetings rehearsals, and moderating the meeting itself. * Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labelling and members of the submission and execution team. Participate in coaching, and performance feedback to members of your GRST. * May (depending on role and project) represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic Regulatory advice and be accountable for all Regulatory activities * Accountable for the delivery of all regulatory milestones on your team including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations. Lead preparation of the regulatory strategy document and target product labeling. * Demonstrate strategic leadership skills contributing to effective product development. Provide team leadership and participate in coaching, and performance feedback to members of the GRST. * Accountable for initiating and delivering key regulatory documents and plans and leading the negotiations with health authorities. * Lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities. * Ensures appropriate planning and construction of the global dossier and core prescribing information led by the respective teams. Accountable for product maintenance, supply and compliance activities associated with marketed brands. * Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance. *Education, Qualifications, Skills and Experience:* *Essential:* * An advanced degree in a science related field and/or other appropriate knowledge/experience. * Previous demonstrated experience of regulatory drug development or equivalent, and experience with major Health Authority interactions. Prior experience with phase 3 design including end of phase 2 health authority interactions is desired. Contribution to a regulatory approval including leading response team and labelling negotiations would be a plus. * A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development. * Demonstrated competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills. * The ability to think strategically and critically and evaluate risks to regulatory activities. *Desirable:* * A good understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design. * Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Experience in relevant therapy area (small molecules & biologics) is preferred. * Ability to work strategically within a complex, business critical and high-profile development program. * Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical components *Location:* Cambridge, UK *Salary:* Competitive + Excellent Benefits *Closing Date:* 30th April 2021 Next steps, if the role looks suitable to you please apply! *Where can I find out more?* Our Social Media, Follow AstraZeneca on LinkedIn []() Follow AstraZeneca on Facebook []() Follow AstraZeneca on Instagram []()
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. If you're a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD is the place to be. Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment - and help get life-changing therapies to patients faster. We have a position open for a Regulatory Affairs Manager. This role provides technical/project leadership across regions, providing innovative solutions including regulatory affairs expertise and client interface to provide strategic regulatory intelligence, and guidance supporting product development from preclinical through registration and product optimization. The role also provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements, and acts as liaison with internal and external clients in the provision and marketing of these services. Responsibilities: * Provide senior review and advice to prepare regional regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements. * Act as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and for key client projects of moderate to high complexity. Provides internal clients with up-to-date legislation and guidance as it becomes available. * Ensure quality performance for key/managed projects. * Manage project budgeting/forecasting functions. * Identify and recognize out of scope activities in a contract in a timely manner and liaise with other departments to follow through on all aspects of contract modifications. * Collaborate with business development in pricing and securing new business by making presentations to clients and developing proposal texts and budget in collaboration with other departments. * Provides matrix/project leadership, training and guidance to junior team members. * Ensure compliance with relevant organizational and regulatory SOPs and WPDs. * Participate in launch meetings, review meetings and project team meetings. *Qualifications:* Job Qualification What the role requires you to have: • Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job, at least 5 years. • Proven project management experience, and experience performing effectively in a client facing role Knowledge, Skills and Abilities: * Excellent English language (written and oral) communication skills as well as local language where applicable * Excellent attention to detail and quality as well as excellent editorial/proofreading skills * Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments * Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies * Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects * Excellent negotiation skills * Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables * Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; advanced understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc. * Superb understanding of medical terminology, statistical concepts, and guidelines * Excellent analytical, investigative and problem-solving skills * Excellent understanding of budgeting and forecasting At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel. - We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing -We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you.
Apr 16, 2021
Full time
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. If you're a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD is the place to be. Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment - and help get life-changing therapies to patients faster. We have a position open for a Regulatory Affairs Manager. This role provides technical/project leadership across regions, providing innovative solutions including regulatory affairs expertise and client interface to provide strategic regulatory intelligence, and guidance supporting product development from preclinical through registration and product optimization. The role also provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements, and acts as liaison with internal and external clients in the provision and marketing of these services. Responsibilities: * Provide senior review and advice to prepare regional regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements. * Act as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and for key client projects of moderate to high complexity. Provides internal clients with up-to-date legislation and guidance as it becomes available. * Ensure quality performance for key/managed projects. * Manage project budgeting/forecasting functions. * Identify and recognize out of scope activities in a contract in a timely manner and liaise with other departments to follow through on all aspects of contract modifications. * Collaborate with business development in pricing and securing new business by making presentations to clients and developing proposal texts and budget in collaboration with other departments. * Provides matrix/project leadership, training and guidance to junior team members. * Ensure compliance with relevant organizational and regulatory SOPs and WPDs. * Participate in launch meetings, review meetings and project team meetings. *Qualifications:* Job Qualification What the role requires you to have: • Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job, at least 5 years. • Proven project management experience, and experience performing effectively in a client facing role Knowledge, Skills and Abilities: * Excellent English language (written and oral) communication skills as well as local language where applicable * Excellent attention to detail and quality as well as excellent editorial/proofreading skills * Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments * Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies * Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects * Excellent negotiation skills * Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables * Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; advanced understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc. * Superb understanding of medical terminology, statistical concepts, and guidelines * Excellent analytical, investigative and problem-solving skills * Excellent understanding of budgeting and forecasting At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel. - We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing -We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you.
Manager, UK Regulatory Affairs!! Project Manage and Lead UK Submissions - Biologics and Pharma Products, but no prior Biotech product experience is required provided there is good UK Affiliate working knowledge. Strong Labelling experience an advantage; CMC and non/CMC combination. A great salary package offered to the right candidate. Are you a UK Regulatory Project Manager or top-end Senior Associate with 3-5+ years' experience, adept in UK Regulatory Strategy and 'hands-on' Regulatory activity? If so, this is the opportunity you have been waiting for!! Reporting to The Head of Regulatory Affairs, you will Project Lead, be Proactive & Advise on UK Regulatory Affairs. Technically, you will have good working knowledge and experience of: New Registrations and Life-cycle management: CTD/Dossiers for MAA's; National Submissions/MRP, DCP and Centralised Procedure. Post Marketing: Type Ia, Ib and II Variations, Renewals and Line Extensions; Labelling, PIL's and SmPC's. Sunset Clauses. BROMI Applications. Past Scientific Advice meetings with the MHRA would be ideal. Candidates from a Pharma, Biotech or Generics background, in UK Regulatory Affairs Development & Strategy and Project Management/Leadership with approximately 4-6+ year's+ solid experience, should be suitable for this position.
Apr 16, 2021
Full time
Manager, UK Regulatory Affairs!! Project Manage and Lead UK Submissions - Biologics and Pharma Products, but no prior Biotech product experience is required provided there is good UK Affiliate working knowledge. Strong Labelling experience an advantage; CMC and non/CMC combination. A great salary package offered to the right candidate. Are you a UK Regulatory Project Manager or top-end Senior Associate with 3-5+ years' experience, adept in UK Regulatory Strategy and 'hands-on' Regulatory activity? If so, this is the opportunity you have been waiting for!! Reporting to The Head of Regulatory Affairs, you will Project Lead, be Proactive & Advise on UK Regulatory Affairs. Technically, you will have good working knowledge and experience of: New Registrations and Life-cycle management: CTD/Dossiers for MAA's; National Submissions/MRP, DCP and Centralised Procedure. Post Marketing: Type Ia, Ib and II Variations, Renewals and Line Extensions; Labelling, PIL's and SmPC's. Sunset Clauses. BROMI Applications. Past Scientific Advice meetings with the MHRA would be ideal. Candidates from a Pharma, Biotech or Generics background, in UK Regulatory Affairs Development & Strategy and Project Management/Leadership with approximately 4-6+ year's+ solid experience, should be suitable for this position.
Associate Director, UK Regulatory Affairs!! Working with the UK General Manager, you will operate as UK Regulatory Affairs Subject Matter Expert. Are you a UK Senior Regulatory Project Manager/Senior Manager with 8+ years' experience, adept in UK Regulatory Strategy and 'hands-on' Regulatory activity? If so, this is the opportunity you have been waiting for!! Superb organisation - a top Biopharma employer with 'cutting-edge' Biopharma Products and very desirable to have on your CV. Close relations with the MHRA are desirable as is Biopharma Product experience. Regulatory Strategy and 'Hands-on', Project Managing in UK Affiliate Market. Operate within a matrix environment and multi-functional teams. Reporting to The Regional Lead Regulatory Affairs, you will Project Lead, be Proactive & Advise on UK Regulatory Affairs. Technically, you will have good working knowledge and experience of: Development and New Registrations: CTA's, IMPD's, IB's, Protocols, up-dates/amendments, End of Trial Notifications, and other Regulatory Development activity; CTD/Dossiers for MAA's; National Submissions/MRP, DCP and Centralised Procedure. Post Marketing: Type Ia, Ib and II Variations, Renewals and Line Extensions; Labelling, PIL's and SmPC's. BROMI Applications. Scientific Advice meetings with the MHRA; PIP's & Orphan Drugs. Rare Diseases & Orphan Drugs. You will be adept in Regulatory Strategy & Tactics and have good experience within a UK Affiliate. Ideally, you will have experience of taking Products from Early & Late Phase, through to successful New Registration and Post Marketing. Candidates from a Biotech, Biopharma or Pharma background, in UK Regulatory Affairs Development & Strategy and Project Management/Leadership with approximately 8 year's+ solid experience, should be suitable for this position.
Apr 16, 2021
Full time
Associate Director, UK Regulatory Affairs!! Working with the UK General Manager, you will operate as UK Regulatory Affairs Subject Matter Expert. Are you a UK Senior Regulatory Project Manager/Senior Manager with 8+ years' experience, adept in UK Regulatory Strategy and 'hands-on' Regulatory activity? If so, this is the opportunity you have been waiting for!! Superb organisation - a top Biopharma employer with 'cutting-edge' Biopharma Products and very desirable to have on your CV. Close relations with the MHRA are desirable as is Biopharma Product experience. Regulatory Strategy and 'Hands-on', Project Managing in UK Affiliate Market. Operate within a matrix environment and multi-functional teams. Reporting to The Regional Lead Regulatory Affairs, you will Project Lead, be Proactive & Advise on UK Regulatory Affairs. Technically, you will have good working knowledge and experience of: Development and New Registrations: CTA's, IMPD's, IB's, Protocols, up-dates/amendments, End of Trial Notifications, and other Regulatory Development activity; CTD/Dossiers for MAA's; National Submissions/MRP, DCP and Centralised Procedure. Post Marketing: Type Ia, Ib and II Variations, Renewals and Line Extensions; Labelling, PIL's and SmPC's. BROMI Applications. Scientific Advice meetings with the MHRA; PIP's & Orphan Drugs. Rare Diseases & Orphan Drugs. You will be adept in Regulatory Strategy & Tactics and have good experience within a UK Affiliate. Ideally, you will have experience of taking Products from Early & Late Phase, through to successful New Registration and Post Marketing. Candidates from a Biotech, Biopharma or Pharma background, in UK Regulatory Affairs Development & Strategy and Project Management/Leadership with approximately 8 year's+ solid experience, should be suitable for this position.
An excellent opportunity has arisen for a contractor to join my client on a 12 month contract basis, working 4 days per week. This is a fully remote based role and the ideal consultant will have a strong background in EU post approval regulatory affairs. Responsibilities * Be a part of the Project management team overseeing successful initiation, execution and completion of Regulatory programs for the clients Global clients. * Responsible for managing project deliverables in line with the project plan * Responsible for compilation, tracking and reporting of the project reports on timely basis. * May have oversight of initiation, execution and completion of projects for the clients clients; and ensuring delivery is within time and budget; if not, take corrective action * Act as a subject matter expert and help the team members with day-to-day trouble shooting activities. * Create high quality reports and other outputs according to the defined specifications to ensure timely reporting of assigned job to project management. * May be a main point of contact for clients, maintaining interactions on a regular basis to understand the client's requirement for a particular project and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints. Candidate Profile: *Educational qualifications (UK): * * A minimum of a graduate degree in Life Sciences * Candidates with experience in Regulatory affairs with exposure to regulatory filings as a part of a pharmaceutical company is preferred * Good knowledge on regulatory requirements and/or guidelines and exposure to relevant document management systems and publishing tools are preferred. Key skill requirement * Experience and knowledge of ICH guidelines and submission requirements of various markets such as USFDA, EMA etc. * Experience and knowledge of EU related procedures (MRP, DCP, CP) for post-approval maintenance submissions * Excellent written communication skills * Working knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel * Core competencies for this role include: * Effective workload management as an individual and as team manager * Analytical capabilities * Professional service mentality - willing to go beyond the call of duty to satisfy their clients * Commitment to highest quality outputs, including obsessive attention to detail * Enthusiasm and pro-activity * Team collaborators, ability to be successful working in teams * * * * *For further details, please contact Tim Barratt on (0) or email *
Apr 16, 2021
Full time
An excellent opportunity has arisen for a contractor to join my client on a 12 month contract basis, working 4 days per week. This is a fully remote based role and the ideal consultant will have a strong background in EU post approval regulatory affairs. Responsibilities * Be a part of the Project management team overseeing successful initiation, execution and completion of Regulatory programs for the clients Global clients. * Responsible for managing project deliverables in line with the project plan * Responsible for compilation, tracking and reporting of the project reports on timely basis. * May have oversight of initiation, execution and completion of projects for the clients clients; and ensuring delivery is within time and budget; if not, take corrective action * Act as a subject matter expert and help the team members with day-to-day trouble shooting activities. * Create high quality reports and other outputs according to the defined specifications to ensure timely reporting of assigned job to project management. * May be a main point of contact for clients, maintaining interactions on a regular basis to understand the client's requirement for a particular project and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints. Candidate Profile: *Educational qualifications (UK): * * A minimum of a graduate degree in Life Sciences * Candidates with experience in Regulatory affairs with exposure to regulatory filings as a part of a pharmaceutical company is preferred * Good knowledge on regulatory requirements and/or guidelines and exposure to relevant document management systems and publishing tools are preferred. Key skill requirement * Experience and knowledge of ICH guidelines and submission requirements of various markets such as USFDA, EMA etc. * Experience and knowledge of EU related procedures (MRP, DCP, CP) for post-approval maintenance submissions * Excellent written communication skills * Working knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel * Core competencies for this role include: * Effective workload management as an individual and as team manager * Analytical capabilities * Professional service mentality - willing to go beyond the call of duty to satisfy their clients * Commitment to highest quality outputs, including obsessive attention to detail * Enthusiasm and pro-activity * Team collaborators, ability to be successful working in teams * * * * *For further details, please contact Tim Barratt on (0) or email *
PLEASE SUBMIT ENGLISH LANGUAGE RESUMES ONLY *Various Seniority Levels * Home-Based/Remote Based Contract Opportunity *Full Time (FTE 1.0) *6+ month duration Do you prefer flexible work options that allow you to work as a contractor, while also being immersed in the PPD Culture? Apply today to learn more about current and upcoming contractor opportunities through our Functional Service Partnership team. Functional Service Partnership Homepage: Position Summary Provides technical/project leadership over a region(s), providing innovative solutions including regulatory affairs expertise and client interface to provide strategic regulatory intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services. *Qualifications:* Essential Functions * Provides senior review and advice to prepare regional regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements. * Acts as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and for key client projects of moderate to high complexity. Provides internal clients with up-to-date legislation and guidance as it becomes available. * Ensures quality performance for key/managed projects. * Manages project budgeting/forecasting functions. * Identifies and recognizes out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications. * Collaborates with business development in pricing and securing new business by making presentations to clients, and develops proposal texts and budgets in collaboration with other departments. * Provides matrix/project leadership, training and guidance to junior team members. * Ensures compliance with relevant organizational and regulatory SOPs and WPDs. * Participates in launch meetings, review meetings and project team meetings. Education and Experience * Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 9+ years). * In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills, and Abilities * Excellent English language (written and oral) communication skills as well as local language where applicable * Excellent attention to detail and quality as well as excellent editorial/proofreading skills * Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments * Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies * Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects * Excellent negotiation skills * Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables * Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; advanced understanding of a regulatory specialty areas, such as preclinical, clinical, CMC, publishing, etc. * Superb understanding of medical terminology, statistical concepts, and guidelines * Excellent analytical, investigative and problem-solving skills * Excellent understanding of budgeting and forecasting PPD is an inclusive equal employment opportunity company. We value all people regardless of background, experience and abilities. PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role * Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. * Able to work upright and stationary for typical working hours. * Ability to use and learn standard office equipment and technology with proficiency. * Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel. (Recruiter will provide more details.)
Apr 16, 2021
Full time
PLEASE SUBMIT ENGLISH LANGUAGE RESUMES ONLY *Various Seniority Levels * Home-Based/Remote Based Contract Opportunity *Full Time (FTE 1.0) *6+ month duration Do you prefer flexible work options that allow you to work as a contractor, while also being immersed in the PPD Culture? Apply today to learn more about current and upcoming contractor opportunities through our Functional Service Partnership team. Functional Service Partnership Homepage: Position Summary Provides technical/project leadership over a region(s), providing innovative solutions including regulatory affairs expertise and client interface to provide strategic regulatory intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services. *Qualifications:* Essential Functions * Provides senior review and advice to prepare regional regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements. * Acts as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and for key client projects of moderate to high complexity. Provides internal clients with up-to-date legislation and guidance as it becomes available. * Ensures quality performance for key/managed projects. * Manages project budgeting/forecasting functions. * Identifies and recognizes out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications. * Collaborates with business development in pricing and securing new business by making presentations to clients, and develops proposal texts and budgets in collaboration with other departments. * Provides matrix/project leadership, training and guidance to junior team members. * Ensures compliance with relevant organizational and regulatory SOPs and WPDs. * Participates in launch meetings, review meetings and project team meetings. Education and Experience * Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 9+ years). * In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills, and Abilities * Excellent English language (written and oral) communication skills as well as local language where applicable * Excellent attention to detail and quality as well as excellent editorial/proofreading skills * Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments * Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies * Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects * Excellent negotiation skills * Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables * Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; advanced understanding of a regulatory specialty areas, such as preclinical, clinical, CMC, publishing, etc. * Superb understanding of medical terminology, statistical concepts, and guidelines * Excellent analytical, investigative and problem-solving skills * Excellent understanding of budgeting and forecasting PPD is an inclusive equal employment opportunity company. We value all people regardless of background, experience and abilities. PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role * Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. * Able to work upright and stationary for typical working hours. * Ability to use and learn standard office equipment and technology with proficiency. * Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel. (Recruiter will provide more details.)
Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist - Publishing/Submissions - Home Based EMEA We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. If you're a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD is the place to be. Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment - and help get life-changing therapies to patients faster. As a Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist, you will electronically publish regulatory documents and submissions via electronic gateways using submission publishing tools. Seeking candidates with experience using Adobe Acrobat, Adobe Acrobat Plug Ins and other submission publishing tools. Summarized Purpose: Provides strategic, expedient and efficient preparation of client electronic submission deliverables and dossiers that meet current local, regional and ICH regulatory and technical requirements. Ensures successful regulatory review outcomes for product milestones. Serves in a technical quality review role and is responsible for the thorough review of published documents and submissions created within or outside of PPD to ensure quality of standards meet regulatory compliance requirements and meet or exceed client expectations. Essential Functions: Provides client electronic submission deliverables supporting regulatory compliance Prepares components of electronic regulatory submissions that meet the electronic document requirements set by regulatory guidance, publishing documents and submissions that work with sponsor and/or regulatory agency software programs, and meeting consistency and data security issues Maintains document lifecycle for submissions Supports development and implementation of project-specific processes for sponsors with unique technology requirements and may act as the PPD liaison for regulatory submission with the sponsor and assist PPD project teams in executing regulatory submission strategies Provides mentoring of other regulatory publishing personnel, as needed Uses professional judgment to evaluate the regulatory publishing needs in relationship to the overall project timelines, quality and delivery Engages other project team members, functional units or publishing management as necessary to deliver final product and resolve/mitigate identified issues or risk to delivery Acts independently within a project team or as the project team lead to evaluate and deliver publishing tasks *LI-SH1 *Qualifications:* Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). Knowledge, Skills and Abilities: Working knowledge of global regulatory requirements and guidances for submission requirements, document management, document publishing and electronic submissions Advanced knowledge of Microsoft (MS) Word, MS Excel, Adobe Acrobat, electronic document management systems, document publishing tools, publishing systems, eCTD validation and viewing tools Advanced knowledge of electronic templates and skilled in formatting and troubleshooting templates Ability to manage several complex projects in parallel and adapt to changing priorities Ability to exercise independent judgment in developing methods, techniques and evaluation of criteria using defined procedures and practices Ability to independently assess sponsor needs and work with project team members in producing compliant deliverables Ability to independently learn new technologies Excellent organizational skills and effective interpersonal skills Excellent analytical ability and problem-solving capabilities Good working knowledge of medical terminology, statistical concepts, and guidelines and requirements of the FDA and other international regulatory agencies Excellent editorial/proofreading skills Detail-oriented, thorough, and methodical Ability to create and follow timelines and conduct long-range planning Ability to multi task performing numerous single or complex tasks without ignoring overall objectives Ability to judge when to initiate changes and make final determinations in the presentation of data in accordance with regulatory guidelines and reviewers' comments Ability to concentrate on the detail in a document without losing sight of the document as a whole At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees. Working Environment: PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel. (Recruiter will provide more details.) PPD Defining Principles: - We have a strong will to win - We earn our customer's trust - We are game changers - We do the right thing - We are one PPD If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you.
Apr 16, 2021
Full time
Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist - Publishing/Submissions - Home Based EMEA We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. If you're a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD is the place to be. Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment - and help get life-changing therapies to patients faster. As a Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist, you will electronically publish regulatory documents and submissions via electronic gateways using submission publishing tools. Seeking candidates with experience using Adobe Acrobat, Adobe Acrobat Plug Ins and other submission publishing tools. Summarized Purpose: Provides strategic, expedient and efficient preparation of client electronic submission deliverables and dossiers that meet current local, regional and ICH regulatory and technical requirements. Ensures successful regulatory review outcomes for product milestones. Serves in a technical quality review role and is responsible for the thorough review of published documents and submissions created within or outside of PPD to ensure quality of standards meet regulatory compliance requirements and meet or exceed client expectations. Essential Functions: Provides client electronic submission deliverables supporting regulatory compliance Prepares components of electronic regulatory submissions that meet the electronic document requirements set by regulatory guidance, publishing documents and submissions that work with sponsor and/or regulatory agency software programs, and meeting consistency and data security issues Maintains document lifecycle for submissions Supports development and implementation of project-specific processes for sponsors with unique technology requirements and may act as the PPD liaison for regulatory submission with the sponsor and assist PPD project teams in executing regulatory submission strategies Provides mentoring of other regulatory publishing personnel, as needed Uses professional judgment to evaluate the regulatory publishing needs in relationship to the overall project timelines, quality and delivery Engages other project team members, functional units or publishing management as necessary to deliver final product and resolve/mitigate identified issues or risk to delivery Acts independently within a project team or as the project team lead to evaluate and deliver publishing tasks *LI-SH1 *Qualifications:* Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). Knowledge, Skills and Abilities: Working knowledge of global regulatory requirements and guidances for submission requirements, document management, document publishing and electronic submissions Advanced knowledge of Microsoft (MS) Word, MS Excel, Adobe Acrobat, electronic document management systems, document publishing tools, publishing systems, eCTD validation and viewing tools Advanced knowledge of electronic templates and skilled in formatting and troubleshooting templates Ability to manage several complex projects in parallel and adapt to changing priorities Ability to exercise independent judgment in developing methods, techniques and evaluation of criteria using defined procedures and practices Ability to independently assess sponsor needs and work with project team members in producing compliant deliverables Ability to independently learn new technologies Excellent organizational skills and effective interpersonal skills Excellent analytical ability and problem-solving capabilities Good working knowledge of medical terminology, statistical concepts, and guidelines and requirements of the FDA and other international regulatory agencies Excellent editorial/proofreading skills Detail-oriented, thorough, and methodical Ability to create and follow timelines and conduct long-range planning Ability to multi task performing numerous single or complex tasks without ignoring overall objectives Ability to judge when to initiate changes and make final determinations in the presentation of data in accordance with regulatory guidelines and reviewers' comments Ability to concentrate on the detail in a document without losing sight of the document as a whole At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees. Working Environment: PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel. (Recruiter will provide more details.) PPD Defining Principles: - We have a strong will to win - We earn our customer's trust - We are game changers - We do the right thing - We are one PPD If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you.
*Global Regulatory Affairs Associate* Middlesex based with some flexibility for home working (1-2 days a week) Salary £35,000 to £45,000 If you're a solidly experienced regulatory affairs professional with some well established global (excluding USA) experience and you'd like to know about a really nice role with a fantastic manager and team it would be great to hear from you. We're working with a specialist, highly regarded global pharmaceutical company. They work with niche products and have a reputation for excellence both in terms of their products and their company. The role we're recruiting for sits in a small, portfolio aligned team in the global regulatory division. You'd be working alongside two other experienced reg affairs colleagues under the leadership of an absolutely great manager. His approach is a combination of supportive and empowering and he's got a strong aversion to micromanagement. The role includes what you'd consider to be core regulatory activities. These include but aren't limited to * Compilation of regulatory submission for new registrations * Renewals, Variations and updates to patient and prescriber information and labelling * Market authorisation transfers * SOP development and creation as they pertain to Regulatory. It's important to note that this is an international team working globally (although not with the FDA / US). Its therefore really important to note that we're looking for someone who has a solid existing level of experience working at that level. Regrettably our client can't consider people who've only worked in the EU or at a limited local regional basis. Specifically we're talking about Asia Pacific, Latin America, Europe (including Central and Eastern Europe) and Africa. What's on offer is an opportunity to work in a genuinely diverse role at a truly international level with some great products and as part of a great team. You'd also be working in a highly cross functional capacity so we're looking for people who don't want to work in a reg affairs bubble and who enjoy interacting with other parts of the business. The company has a reputation for developing their people and have a in house training function that empowers people to grow their careers into different areas. That might be project management or a commercial or other aligned function. They're also very focused on employee support and well being and have tangibly demonstrated this throughout the last year. The big sell for me on this role is the manager. He's a very experienced, well respected reg affairs leader who I've known for years. Incredibly strong technically and highly engaging and likable he's the kind of person who'd make a great boss. What I'm looking for in summary is; Someone with 2-5 years experience with a broad, international reg affairs role with pharma products as well as good secondary competencies / understanding of GMP from a reg affairs perspective A self starter who can effectively manage their own time and priorities. If that sounds interesting I'd love to hear from you so that I can tell you more.
Apr 16, 2021
Full time
*Global Regulatory Affairs Associate* Middlesex based with some flexibility for home working (1-2 days a week) Salary £35,000 to £45,000 If you're a solidly experienced regulatory affairs professional with some well established global (excluding USA) experience and you'd like to know about a really nice role with a fantastic manager and team it would be great to hear from you. We're working with a specialist, highly regarded global pharmaceutical company. They work with niche products and have a reputation for excellence both in terms of their products and their company. The role we're recruiting for sits in a small, portfolio aligned team in the global regulatory division. You'd be working alongside two other experienced reg affairs colleagues under the leadership of an absolutely great manager. His approach is a combination of supportive and empowering and he's got a strong aversion to micromanagement. The role includes what you'd consider to be core regulatory activities. These include but aren't limited to * Compilation of regulatory submission for new registrations * Renewals, Variations and updates to patient and prescriber information and labelling * Market authorisation transfers * SOP development and creation as they pertain to Regulatory. It's important to note that this is an international team working globally (although not with the FDA / US). Its therefore really important to note that we're looking for someone who has a solid existing level of experience working at that level. Regrettably our client can't consider people who've only worked in the EU or at a limited local regional basis. Specifically we're talking about Asia Pacific, Latin America, Europe (including Central and Eastern Europe) and Africa. What's on offer is an opportunity to work in a genuinely diverse role at a truly international level with some great products and as part of a great team. You'd also be working in a highly cross functional capacity so we're looking for people who don't want to work in a reg affairs bubble and who enjoy interacting with other parts of the business. The company has a reputation for developing their people and have a in house training function that empowers people to grow their careers into different areas. That might be project management or a commercial or other aligned function. They're also very focused on employee support and well being and have tangibly demonstrated this throughout the last year. The big sell for me on this role is the manager. He's a very experienced, well respected reg affairs leader who I've known for years. Incredibly strong technically and highly engaging and likable he's the kind of person who'd make a great boss. What I'm looking for in summary is; Someone with 2-5 years experience with a broad, international reg affairs role with pharma products as well as good secondary competencies / understanding of GMP from a reg affairs perspective A self starter who can effectively manage their own time and priorities. If that sounds interesting I'd love to hear from you so that I can tell you more.
Junior Security Project Manager £350 - £400 per day (inside of IR35) Full time, initial 6 month contract London (remote to start) Our public sector client is on the lookout for a Junior Security Project Manager to join them on an initial 6 month contract, as part of an initiative bringing together a number of large and complex programmes which together will improve collaboration and integration between t...... click apply for full job details
Apr 16, 2021
Full time
Junior Security Project Manager £350 - £400 per day (inside of IR35) Full time, initial 6 month contract London (remote to start) Our public sector client is on the lookout for a Junior Security Project Manager to join them on an initial 6 month contract, as part of an initiative bringing together a number of large and complex programmes which together will improve collaboration and integration between t...... click apply for full job details
Job Title: Security Officer Location: Kingston upon Thames (KT1 2EE) Salary: £27,870 per annum Job type: Permanent, Day / Night Shift - Predominantly Nights (7am -7pm OR 7pm - 7am, 4 days on 4 days off) KUSCO are currently looking for a Security officer to join their team covering all of Kingston University's sites. You will be required to operate flexible hours, as 24 hour 365 day a year cover is provided by this service to multiple sites Key Responsibilities: To ensure the safety and security of staff, students and visitors at any Kingston University site Maintain accurate record to ensure information is available for the Duty Security Supervisor and Hall Manager Take appropriate action to handle and contain incidents sensitively (e.g. aggression, theft). Ensure as much information as possible is available (e.g. carry out ID checks) Provide first aid as needed. This may include making calls to Thamesdoc or to the emergency services Deal sensitively with distressed students, providing general advice on University services available Attend and take control of, emergency incidents such as Fire Alarms, following procedures, calling Emergency services and re-setting alarms as necessary Deal with emergency maintenance issues that may occur during a shift, varying from personally carrying out emergency lock changes to student bedrooms in cases of loss/theft of keys to contacting Responsive Maintenance call-out Ensure the University parking regulations are upheld, and wherever possible preventing/reporting dangerous driving In any emergency situation to immediately contact Shift Supervisor and/or police if applicable Respond to all alarm activations including fire, access control, intruder and panic alarms Develop and maintain good working relationships with both University and external authorities (including emergency services) to ensure their continuing support, understanding and assistance Develop good relationships with staff, students, contractors and visitors; explain clearly the Security and Health & Safety regulations they need to understand, and provide them with information on security they require Where necessary to drive Security mobile vehicle and act as support to other officers To understand and follow Security Standing Orders and Assignment Instructions Any other duties as may be reasonably required, which may include ensuring good student behaviour in Computer rooms on main campus sites during the evening The Candidate: Essential: A current SIA Manned Guarding Licence/Door Supervision A current SIA CCTV Licence Current and valid manual UK driving licence 5 year verifiable work record Ability to work in a team and independently with a professional approach which generates credibility and confidence in others The ability, tact and diplomacy to deal with people including our client, the client's staff and visitors in all circumstances including emergencies and other times of stress Flexibility and self-motivation with good organisation skills, ability to work with little direct supervision and to prioritise tasks if necessary on a daily basis Excellent communication skills - both verbal and written Ability to listen to problems and to explain clearly actions to be taken An excellent level of physical fitness to be able to perform patrol and emergency response duties efficiently and effectively A consistently smart appearance in the uniform provided and required by KUSCO Ability to be vigilant at all times and notice details of what is happening Knowledge of the job and safe working practices (HASAW) Desirable: Minimum of 3 years relevant experience Previous experience of working in a University environment Qualified First Aider Please click on the APPLY button to send your CV and Cover Letter for this role. Candidates with the relevant experience or job titles of; Corporate Security, Security Officer, Security Guard, Experienced Security Officer, Security, Security Enforcement Officer, SIA Licence, SIA Licenced Security Officer, CCTV, Security Support Officer may also be considered for this role.
Apr 16, 2021
Full time
Job Title: Security Officer Location: Kingston upon Thames (KT1 2EE) Salary: £27,870 per annum Job type: Permanent, Day / Night Shift - Predominantly Nights (7am -7pm OR 7pm - 7am, 4 days on 4 days off) KUSCO are currently looking for a Security officer to join their team covering all of Kingston University's sites. You will be required to operate flexible hours, as 24 hour 365 day a year cover is provided by this service to multiple sites Key Responsibilities: To ensure the safety and security of staff, students and visitors at any Kingston University site Maintain accurate record to ensure information is available for the Duty Security Supervisor and Hall Manager Take appropriate action to handle and contain incidents sensitively (e.g. aggression, theft). Ensure as much information as possible is available (e.g. carry out ID checks) Provide first aid as needed. This may include making calls to Thamesdoc or to the emergency services Deal sensitively with distressed students, providing general advice on University services available Attend and take control of, emergency incidents such as Fire Alarms, following procedures, calling Emergency services and re-setting alarms as necessary Deal with emergency maintenance issues that may occur during a shift, varying from personally carrying out emergency lock changes to student bedrooms in cases of loss/theft of keys to contacting Responsive Maintenance call-out Ensure the University parking regulations are upheld, and wherever possible preventing/reporting dangerous driving In any emergency situation to immediately contact Shift Supervisor and/or police if applicable Respond to all alarm activations including fire, access control, intruder and panic alarms Develop and maintain good working relationships with both University and external authorities (including emergency services) to ensure their continuing support, understanding and assistance Develop good relationships with staff, students, contractors and visitors; explain clearly the Security and Health & Safety regulations they need to understand, and provide them with information on security they require Where necessary to drive Security mobile vehicle and act as support to other officers To understand and follow Security Standing Orders and Assignment Instructions Any other duties as may be reasonably required, which may include ensuring good student behaviour in Computer rooms on main campus sites during the evening The Candidate: Essential: A current SIA Manned Guarding Licence/Door Supervision A current SIA CCTV Licence Current and valid manual UK driving licence 5 year verifiable work record Ability to work in a team and independently with a professional approach which generates credibility and confidence in others The ability, tact and diplomacy to deal with people including our client, the client's staff and visitors in all circumstances including emergencies and other times of stress Flexibility and self-motivation with good organisation skills, ability to work with little direct supervision and to prioritise tasks if necessary on a daily basis Excellent communication skills - both verbal and written Ability to listen to problems and to explain clearly actions to be taken An excellent level of physical fitness to be able to perform patrol and emergency response duties efficiently and effectively A consistently smart appearance in the uniform provided and required by KUSCO Ability to be vigilant at all times and notice details of what is happening Knowledge of the job and safe working practices (HASAW) Desirable: Minimum of 3 years relevant experience Previous experience of working in a University environment Qualified First Aider Please click on the APPLY button to send your CV and Cover Letter for this role. Candidates with the relevant experience or job titles of; Corporate Security, Security Officer, Security Guard, Experienced Security Officer, Security, Security Enforcement Officer, SIA Licence, SIA Licenced Security Officer, CCTV, Security Support Officer may also be considered for this role.
CK Group are recruiting for a Regulatory Operations Submission Manager to join a company in the Pharmaceutical industry. The role is remote working however some occasional travel to the site in Macclesfield will be required. The role is being offered on a contract basis for 6-12 months. *Salary:* £600 per day (outside IR35) LTD / Umbrella *Regulatory Operations Submission Manager Role:* * Responsible for delivery and life cycle management of regulatory submission documents working within Global Technical Operations * Lead or participate in cross-functional teams as the BioOps representative to provide submission related expertise * Lead the process of critical review of CMC regulatory documents and incorporating multiple internal and external reviews into quality documents * Manage activities associated with multiple projects: delivery of documents to submission ready standards * Participate or lead template and procedure preparations *Your Background:* * BS/MSc in a scientific discipline relevant to manufacturing and drug development of biologics products, such as cell culture, purification, analytical biochemistry, formulation, device, etc. * 6+ years of biopharmaceutical industry experience, including 2 years of writing experience in a regulatory environment. * Experience preparing CMC regulatory documents and/or manuscripts is desired. * Background in biologics such as monoclonal antibodies and/or vaccines. * Must have strong interpersonal skills and an ability to influence. *Company:* Our client is a global pharmaceutical company with a major presence in the UK. Their purpose is to deliver life-changing medicines and to do this they are completely science-led and like to share this with the scientific, healthcare and business communities within the UK. *Location:* This Regulatory Operations Submission Manager role will be based at our clients site in Macclesfield, Cheshire. *Apply:* Please quote reference 50309.
Apr 16, 2021
Full time
CK Group are recruiting for a Regulatory Operations Submission Manager to join a company in the Pharmaceutical industry. The role is remote working however some occasional travel to the site in Macclesfield will be required. The role is being offered on a contract basis for 6-12 months. *Salary:* £600 per day (outside IR35) LTD / Umbrella *Regulatory Operations Submission Manager Role:* * Responsible for delivery and life cycle management of regulatory submission documents working within Global Technical Operations * Lead or participate in cross-functional teams as the BioOps representative to provide submission related expertise * Lead the process of critical review of CMC regulatory documents and incorporating multiple internal and external reviews into quality documents * Manage activities associated with multiple projects: delivery of documents to submission ready standards * Participate or lead template and procedure preparations *Your Background:* * BS/MSc in a scientific discipline relevant to manufacturing and drug development of biologics products, such as cell culture, purification, analytical biochemistry, formulation, device, etc. * 6+ years of biopharmaceutical industry experience, including 2 years of writing experience in a regulatory environment. * Experience preparing CMC regulatory documents and/or manuscripts is desired. * Background in biologics such as monoclonal antibodies and/or vaccines. * Must have strong interpersonal skills and an ability to influence. *Company:* Our client is a global pharmaceutical company with a major presence in the UK. Their purpose is to deliver life-changing medicines and to do this they are completely science-led and like to share this with the scientific, healthcare and business communities within the UK. *Location:* This Regulatory Operations Submission Manager role will be based at our clients site in Macclesfield, Cheshire. *Apply:* Please quote reference 50309.
Security Officer Location - Stone, ST15 Hours - Monday -Sunday, day and night shifts (will also include bank holidays) Apleona is an equal opportunities employer who deliver facilities management services to clients all over the UK and Ireland and with vacancies in your area this is a great time to join our teams...... click apply for full job details
Apr 16, 2021
Full time
Security Officer Location - Stone, ST15 Hours - Monday -Sunday, day and night shifts (will also include bank holidays) Apleona is an equal opportunities employer who deliver facilities management services to clients all over the UK and Ireland and with vacancies in your area this is a great time to join our teams...... click apply for full job details
Year-on-year, as we continue to grow, we need to work as smart as we can, to keep all our team members safe, fulfilled, motivated and empowered. To enable us achieve this, we're seeking an enthusiastic Workplace Health and Safety Specialist. With your Bias for Action we will need you to step in and support the Workplace Health and Safety (WHS) team in one of our Fulfillment Centres. The ideal candidate will be an experienced, innovative and hands-on person who is enthusiastic about Health and Safety in a professional context. In time, we'll expect you to become as customer-centric as we are and apply this to your work each day. You will also need to be able to identify, coordinate and promote improvements in Workplace Health and Safety, while engaging operational and other support function stakeholders. The WHS Specialist will report directly to the Fulfillment Centre WHS Manager. Responsibilities · Assisting with the delivery of safety performance and monitoring, in line with personnel, team and functional goals and objectives · Facilitating and/or arranging training programs on critical Fulfillment Centre WHS issues, and the training of new Health and Safety team members · Supporting the implementation of WHS programs within Fulfillment Centre Operations, while delivering key risk assessment activities · Promoting compliance with local and EU legislation, and participating in the EU Fulfilment Centre EHS Safety Audit Programme · Ensuring that WHS systems are kept accurate at all times, with completed incident reports, alongside all supporting documentation, and assisting the WHS Manager with the construction of incident prevention programs · Contributing to Fulfilment Centre requests for improvement of on-site safety and positively impact accident trends · Preparing responses to insurers or solicitors in response to any personal injury claims · Acting as a proxy for the EHS Manager, as and when required · Arranging, facilitating and contributing to Fulfilment Centre Safety Steering Committee meetings Arranging and conducting basic surveys and checks in the Fulfillment Centre environment, looking into facility processes, Health and Safety supplies as well as employee behaviours. BASIC QUALIFICATIONS · You're qualified to NEBOSH Diploma/NVQ5 level or equivalent qualification, or you hold degree level qualifications in any subject and are willing to complete these or equivalent qualifications within an agreed timescale. · You're able to demonstrate an in-depth understanding of essential Environment, Health and Safety legislation · Candidates with relevant experience, from backgrounds that may differ from Safety disciplines, will also be considered. PREFERRED QUALIFICATIONS Amazon is an equal opportunities employer. We believe passionately that employing a diverse workforce is central to our success. We make recruiting decisions based on your experience and skills. We value your passion to discover, invent, simplify and build. Protecting your privacy and the security of your data is a longstanding top priority for Amazon. Please consult our Privacy Notice to know more about how we collect, use and transfer the personal data of our candidates.
Apr 16, 2021
Full time
Year-on-year, as we continue to grow, we need to work as smart as we can, to keep all our team members safe, fulfilled, motivated and empowered. To enable us achieve this, we're seeking an enthusiastic Workplace Health and Safety Specialist. With your Bias for Action we will need you to step in and support the Workplace Health and Safety (WHS) team in one of our Fulfillment Centres. The ideal candidate will be an experienced, innovative and hands-on person who is enthusiastic about Health and Safety in a professional context. In time, we'll expect you to become as customer-centric as we are and apply this to your work each day. You will also need to be able to identify, coordinate and promote improvements in Workplace Health and Safety, while engaging operational and other support function stakeholders. The WHS Specialist will report directly to the Fulfillment Centre WHS Manager. Responsibilities · Assisting with the delivery of safety performance and monitoring, in line with personnel, team and functional goals and objectives · Facilitating and/or arranging training programs on critical Fulfillment Centre WHS issues, and the training of new Health and Safety team members · Supporting the implementation of WHS programs within Fulfillment Centre Operations, while delivering key risk assessment activities · Promoting compliance with local and EU legislation, and participating in the EU Fulfilment Centre EHS Safety Audit Programme · Ensuring that WHS systems are kept accurate at all times, with completed incident reports, alongside all supporting documentation, and assisting the WHS Manager with the construction of incident prevention programs · Contributing to Fulfilment Centre requests for improvement of on-site safety and positively impact accident trends · Preparing responses to insurers or solicitors in response to any personal injury claims · Acting as a proxy for the EHS Manager, as and when required · Arranging, facilitating and contributing to Fulfilment Centre Safety Steering Committee meetings Arranging and conducting basic surveys and checks in the Fulfillment Centre environment, looking into facility processes, Health and Safety supplies as well as employee behaviours. BASIC QUALIFICATIONS · You're qualified to NEBOSH Diploma/NVQ5 level or equivalent qualification, or you hold degree level qualifications in any subject and are willing to complete these or equivalent qualifications within an agreed timescale. · You're able to demonstrate an in-depth understanding of essential Environment, Health and Safety legislation · Candidates with relevant experience, from backgrounds that may differ from Safety disciplines, will also be considered. PREFERRED QUALIFICATIONS Amazon is an equal opportunities employer. We believe passionately that employing a diverse workforce is central to our success. We make recruiting decisions based on your experience and skills. We value your passion to discover, invent, simplify and build. Protecting your privacy and the security of your data is a longstanding top priority for Amazon. Please consult our Privacy Notice to know more about how we collect, use and transfer the personal data of our candidates.
At AstraZeneca, we make a difference every day by delivering life-changing medicines to millions of people globally. Creating a more agile and inclusive environment means building an inspiring culture where we celebrate innovative thinking. This means we are opening up new ways to work, ground-breaking methods and bringing excellent teams together. Above all, we are passionate about science and driven to always put patients first. Join us and be part of an exceptional place to work! We have an opportunity for a *Regulatory Affairs Director (RAD) - Emerging Markets *to join our team. Emerging Markets Regulatory Affairs (EMRA) drive innovative, international, regulatory and patient-centric strategies enabling simultaneous global access to our products. We have a three-pillar strategy in Emerging Markets: Expansion, Innovation and Partnership. You will provide strategic leadership and have an understanding of regulatory science across international regions. Your experience and knowledge of drug/biologic development processes and strategies will enable you to influence cross-functional discussions with product teams. A thorough understanding of international commercial factors is needed for success in this role. *Key accountabilities / responsibilities: * *Project Regulatory Strategy* * Development and implementation of innovative regulatory strategies designed to deliver a rapid approval. Strategy should reflect international requirements. * Develop, communicate and update the International section of the Regulatory Strategy Document for assigned products/projects. * Delivery of regulatory milestones including assessment of the probability of regulatory success together with risk and mitigation measures. * Lead the objective assessment of emerging data against aspirations and update leadership teams on project risks and mitigation activities. *Leadership* * Single point of contact and Regional Regulatory Affairs representative on Regional Product Teams (across the Emerging Markets) * Planning and creation of the International dossier * Build and implement an optimal regulatory strategy for product(s) ensuring International needs are incorporated into the Global Regulatory Strategy that in turn contributes to the Global Product Development Plan. * Ensure business needs are understood within the Global Regulatory Strategy Team; encourage regional commercial engagement with proposed regulatory strategies, risks and mitigation plans. * Ensure effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements. * Coach, mentor and lead regulatory teams to ensure objectives are successfully delivered to time and quality. * Provide leadership in product in-license/due diligence review, product divestment and product withdrawal. * Proactively contribute across RAD community and Regulatory Excellence objectives and activities. *Regulatory Environment* * Partner with commercial teams to monitor changes in the regulatory environment; support and advise accordingly. * Collaborate with commercial colleagues to influence guidance within leading Health Authorities. *Essential Criteria:* * Bachelor's degree in a science related field * Previous experience with Major Health Authority interactions * Extensive knowledge of regulatory drug development including product approval/launch. * Broad background in pharmaceutical business and experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority. * Leadership and program management experience. * Ability to think strategically and critically evaluate risks to regulatory activities within a complex, critical, high-profile development program. * Successful contribution to a major regulatory approval in the International Region * Commercial and cross-cultural awareness; can work independently with Commercial and Marketing Company colleagues from across the globe. * Must demonstrate competencies of: critical thinking, strategic influencing, innovation, initiative, leadership and proficiency with both written and verbal communications. *Location: Cambridge UK, other locations can be considered*
Apr 16, 2021
Full time
At AstraZeneca, we make a difference every day by delivering life-changing medicines to millions of people globally. Creating a more agile and inclusive environment means building an inspiring culture where we celebrate innovative thinking. This means we are opening up new ways to work, ground-breaking methods and bringing excellent teams together. Above all, we are passionate about science and driven to always put patients first. Join us and be part of an exceptional place to work! We have an opportunity for a *Regulatory Affairs Director (RAD) - Emerging Markets *to join our team. Emerging Markets Regulatory Affairs (EMRA) drive innovative, international, regulatory and patient-centric strategies enabling simultaneous global access to our products. We have a three-pillar strategy in Emerging Markets: Expansion, Innovation and Partnership. You will provide strategic leadership and have an understanding of regulatory science across international regions. Your experience and knowledge of drug/biologic development processes and strategies will enable you to influence cross-functional discussions with product teams. A thorough understanding of international commercial factors is needed for success in this role. *Key accountabilities / responsibilities: * *Project Regulatory Strategy* * Development and implementation of innovative regulatory strategies designed to deliver a rapid approval. Strategy should reflect international requirements. * Develop, communicate and update the International section of the Regulatory Strategy Document for assigned products/projects. * Delivery of regulatory milestones including assessment of the probability of regulatory success together with risk and mitigation measures. * Lead the objective assessment of emerging data against aspirations and update leadership teams on project risks and mitigation activities. *Leadership* * Single point of contact and Regional Regulatory Affairs representative on Regional Product Teams (across the Emerging Markets) * Planning and creation of the International dossier * Build and implement an optimal regulatory strategy for product(s) ensuring International needs are incorporated into the Global Regulatory Strategy that in turn contributes to the Global Product Development Plan. * Ensure business needs are understood within the Global Regulatory Strategy Team; encourage regional commercial engagement with proposed regulatory strategies, risks and mitigation plans. * Ensure effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements. * Coach, mentor and lead regulatory teams to ensure objectives are successfully delivered to time and quality. * Provide leadership in product in-license/due diligence review, product divestment and product withdrawal. * Proactively contribute across RAD community and Regulatory Excellence objectives and activities. *Regulatory Environment* * Partner with commercial teams to monitor changes in the regulatory environment; support and advise accordingly. * Collaborate with commercial colleagues to influence guidance within leading Health Authorities. *Essential Criteria:* * Bachelor's degree in a science related field * Previous experience with Major Health Authority interactions * Extensive knowledge of regulatory drug development including product approval/launch. * Broad background in pharmaceutical business and experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority. * Leadership and program management experience. * Ability to think strategically and critically evaluate risks to regulatory activities within a complex, critical, high-profile development program. * Successful contribution to a major regulatory approval in the International Region * Commercial and cross-cultural awareness; can work independently with Commercial and Marketing Company colleagues from across the globe. * Must demonstrate competencies of: critical thinking, strategic influencing, innovation, initiative, leadership and proficiency with both written and verbal communications. *Location: Cambridge UK, other locations can be considered*
This is is availabile at any of our UK sites (Stevenage, Bristol and Bolton) A leading trans-national defence company are looking for a highly motivated individual to lead a multi-skilled security team. The role encapsulates a wide and diverse area of security disciplines and requires someone who will be able to provide and deliver security solutions to the many and varied challenges across the UK ...... click apply for full job details
Apr 16, 2021
Full time
This is is availabile at any of our UK sites (Stevenage, Bristol and Bolton) A leading trans-national defence company are looking for a highly motivated individual to lead a multi-skilled security team. The role encapsulates a wide and diverse area of security disciplines and requires someone who will be able to provide and deliver security solutions to the many and varied challenges across the UK ...... click apply for full job details
STARS at Securitas provide a "two roles in one" service to our clients, their staff, visitors and customers. We combine excellent customer service across a wide range of roles including Reception Services, Front of House, Concierge, Facilities, Office Management/Coordination, Administration and much more with a discreet and vigilant security service. Our STARS deliver a consistently high-end, comprehensive and discreet security-focused hosting experience to all visitors, guests and employees at the designated site(s). STARS ensure the safety and protection of customer's people, property and information always, in a knowledgeable, professional and service-oriented manner, ensuring an unobtrusive and comfortable environment. STARS are the recognised central point of contact for all Front of House operations, delivering a smooth and seamless execution throughout the premises. We combine first-class, SIA-approved security expertise with exceptional customer service delivery. Vetted to BS7858 our STARS complete bespoke training, tailored to meet the specific needs of our clients. Learn more about the Security Trained Assistance and Reception Services (STARS) Programme here: https://services/on-site/stars/ How you will make an impact as a member of the STARS Programme: Deliver a consistently high-end customer focussed experience Embody a high-performance approach and encourage colleagues to do the same Ensure the workplace (reception, lobby, office, etc.) is visually of a high standard Provide timely and accurate information Respond appropriately to varying and fast changing priorities Build strong rapport with reoccurring customers (client staff, visitors, contractors, etc.) Represent Securitas and the client organisation in a manner that is in-keeping with the values, brand identity and culture of both Additional Information: This role will be based on our client site in Coventry with the following shift pattern: Monday - Friday, 60 hours per week (shift times TBC) Essential Skills What you will bring to be a member of the STARS Programme: Experience within facilities / office coordination Highest quality personal appearance Flexible, professional and adept at working under pressure Outstanding written, verbal and oral communication skills Customer oriented with a passion for high-level service Working knowledge of administrative computer packages such as MS Office, GSuite, etc. Polite and proactive Punctual and trustworthy Able to use initiative and highly adaptable Experienced in Customer Service, Front of House, Concierge, Hosting or Customer facing role ideally within a corporate environment Demonstrate the values of integrity, vigilance and helpfulness which Securitas prides itself on SIA licence holders preferred About Company Securitas Benefits: Paid holiday, company pension and life assurance scheme Discounted gym membership Wellness advice and support Cycle to Work Scheme Car lease and new car purchasing schemes Employee discounts and cashback savings across hundreds of your favourite high street brands, online shopping, holidays, and days out. City & Guilds accredited training program for professional and personal development Support to gain your SIA license Here at Securitas we guard and protect a variety of clients across the globe, these range from banks, retail chains, and leisure venues through to corporate offices. Our employees play an integral role in making people feel safe. Securitas is encouraging and empowering diversity & inclusion in the workplace and has been recognised with both UK SuperBrand and UK Top Employer awards for 2019/20. Our values are the foundation of our operations and the corporate culture is built on these values that help to shape a long-term, financially successful enterprise by creating value for customers, employees, and shareholders. They are summarized in three words: Integrity , Vigilance , and Helpfulness . With our roots dating back to 1934, Securitas is one of the largest security service organizations in the world, we have around 150,000 clients, of which 150 are globally listed companies. We specialize in protecting corporate organizations, small to medium-sized businesses, and the public so a successful applicant will join an industry leader with over 370,000 employees, of which 9,500 are in the UK. We are a company where you can develop your Security career, with access to training and the ability to gain professionally recognised qualifications so you can grow in confidence and take on more responsibility. If you want to know more about why Securitas is the world's leading security group, and our continuing work in the diversity & inclusion space, simply visit: en-GB/ Join the Securitas Team today!
Apr 16, 2021
Full time
STARS at Securitas provide a "two roles in one" service to our clients, their staff, visitors and customers. We combine excellent customer service across a wide range of roles including Reception Services, Front of House, Concierge, Facilities, Office Management/Coordination, Administration and much more with a discreet and vigilant security service. Our STARS deliver a consistently high-end, comprehensive and discreet security-focused hosting experience to all visitors, guests and employees at the designated site(s). STARS ensure the safety and protection of customer's people, property and information always, in a knowledgeable, professional and service-oriented manner, ensuring an unobtrusive and comfortable environment. STARS are the recognised central point of contact for all Front of House operations, delivering a smooth and seamless execution throughout the premises. We combine first-class, SIA-approved security expertise with exceptional customer service delivery. Vetted to BS7858 our STARS complete bespoke training, tailored to meet the specific needs of our clients. Learn more about the Security Trained Assistance and Reception Services (STARS) Programme here: https://services/on-site/stars/ How you will make an impact as a member of the STARS Programme: Deliver a consistently high-end customer focussed experience Embody a high-performance approach and encourage colleagues to do the same Ensure the workplace (reception, lobby, office, etc.) is visually of a high standard Provide timely and accurate information Respond appropriately to varying and fast changing priorities Build strong rapport with reoccurring customers (client staff, visitors, contractors, etc.) Represent Securitas and the client organisation in a manner that is in-keeping with the values, brand identity and culture of both Additional Information: This role will be based on our client site in Coventry with the following shift pattern: Monday - Friday, 60 hours per week (shift times TBC) Essential Skills What you will bring to be a member of the STARS Programme: Experience within facilities / office coordination Highest quality personal appearance Flexible, professional and adept at working under pressure Outstanding written, verbal and oral communication skills Customer oriented with a passion for high-level service Working knowledge of administrative computer packages such as MS Office, GSuite, etc. Polite and proactive Punctual and trustworthy Able to use initiative and highly adaptable Experienced in Customer Service, Front of House, Concierge, Hosting or Customer facing role ideally within a corporate environment Demonstrate the values of integrity, vigilance and helpfulness which Securitas prides itself on SIA licence holders preferred About Company Securitas Benefits: Paid holiday, company pension and life assurance scheme Discounted gym membership Wellness advice and support Cycle to Work Scheme Car lease and new car purchasing schemes Employee discounts and cashback savings across hundreds of your favourite high street brands, online shopping, holidays, and days out. City & Guilds accredited training program for professional and personal development Support to gain your SIA license Here at Securitas we guard and protect a variety of clients across the globe, these range from banks, retail chains, and leisure venues through to corporate offices. Our employees play an integral role in making people feel safe. Securitas is encouraging and empowering diversity & inclusion in the workplace and has been recognised with both UK SuperBrand and UK Top Employer awards for 2019/20. Our values are the foundation of our operations and the corporate culture is built on these values that help to shape a long-term, financially successful enterprise by creating value for customers, employees, and shareholders. They are summarized in three words: Integrity , Vigilance , and Helpfulness . With our roots dating back to 1934, Securitas is one of the largest security service organizations in the world, we have around 150,000 clients, of which 150 are globally listed companies. We specialize in protecting corporate organizations, small to medium-sized businesses, and the public so a successful applicant will join an industry leader with over 370,000 employees, of which 9,500 are in the UK. We are a company where you can develop your Security career, with access to training and the ability to gain professionally recognised qualifications so you can grow in confidence and take on more responsibility. If you want to know more about why Securitas is the world's leading security group, and our continuing work in the diversity & inclusion space, simply visit: en-GB/ Join the Securitas Team today!
*Company * BAP Pharma are Global Leaders in Clinical Trails supply, specialising in comparator sourcing and secondary packaging. Founded in 2011, BAP Pharma, is an incredible story of growth and success, steadily expanding its operations into different countries, with a presence in the UK, USA and Germany. We are a team of professionals who have a passion for delivering on our promises to each other and our customers. We are driven to create exceptional value and an unrivalled service. Our culture is one of openness, honesty and respect and our goal is to become the Global Leader in the Clinical Trails Supply Industry, known for our innovation, expertise, ethics and dedication to providing excellent customer services. We are now looking for people with a passion for great customer service and doing the right thing, to help us take the business forward. Our people are our greatest asset, without them we will not be able to deliver on our promises. Our future is exciting, come join us! *Job Description* BAP have an amazing opportunity for a Regulatory Affairs to join our busy and growing team. The Regulatory Affairs Officer will support the Regulatory Affairs and Pharmacovigilance manager with all associated BAP Pharma regulatory activities. The role will also contribute to the implementation, leading of projects and building of expertise within the Unlicensed Medicines space. *Responsibilities include:-* * Support the Regulatory Affairs and Pharmacovigilance Manager with day to day regulatory responsibilities and build Regulatory Expertise and provide regular update's * Attend relevant team and client meetings with cross-divisional colleagues to provide technical guidance and support for teams as necessary. * Ensuring team members understand the potential opportunities and constraints that the latest legislation/upcoming changes to legislation might create for their commercial activities * Facilitate cross-functional awareness and understanding of regulatory issues. * Providing Regulatory Advice and Information to meet Customer and colleague requests. * Using knowledge of EU/national legislation, guidelines and regulatory environment to provide insightful responses to enquiries. * Advise on matters of compliance, regulatory requirements and regulatory policy * In partnership with operational hubs respond to Regulatory Authority queries and input to aggregate safety reports * Respond to requests from authorities promptly and accurately * Assist in populating and maintaining Regulatory Databases. Responsible for database entry and the document management of regulatory transactions undertaken at local level * Participate in ad hoc and routine QC checking of regulatory data bases * Obtain Authority Approvals for Supply of Unlicensed Medicines * Obtain necessary approvals to import and supply unlicensed medicines for unmet patient needs * Ensure implementation of Good Regulatory Practice (GRP) and Adhere to relevant procedures and practices to ensure GRP is maintained * Maintenance of regulatory activities in line with company procedures. *Requirements*. * Life sciences or chemistry graduate to honours level or equivalent, Master's degree preferred * Previous experience in Regulatory Affairs (Human Medicinal Products) preferred * Member of The Organisation for Professionals in Regulatory Affairs (TOPRA) desirable * Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory Affairs) * Knowledge of the global unlicensed medicines market and or the Pharmaceutical industry is desirable *Competencies* * Excellent communication skills with internal and external partners * Analytical thinking and Ability to prioritise effectively * Results focused with attention to detail * Ability to multitask with excellent written and verbal communication skills * Able to work on own and make decisions independently, where needed This role reports to the Global Medicines Access Director. Overtime may be required from time to time to meet project deadlines. We have a diverse range of employees with different cultures and backgrounds and are committed to diversity and inclusion.
Apr 16, 2021
Full time
*Company * BAP Pharma are Global Leaders in Clinical Trails supply, specialising in comparator sourcing and secondary packaging. Founded in 2011, BAP Pharma, is an incredible story of growth and success, steadily expanding its operations into different countries, with a presence in the UK, USA and Germany. We are a team of professionals who have a passion for delivering on our promises to each other and our customers. We are driven to create exceptional value and an unrivalled service. Our culture is one of openness, honesty and respect and our goal is to become the Global Leader in the Clinical Trails Supply Industry, known for our innovation, expertise, ethics and dedication to providing excellent customer services. We are now looking for people with a passion for great customer service and doing the right thing, to help us take the business forward. Our people are our greatest asset, without them we will not be able to deliver on our promises. Our future is exciting, come join us! *Job Description* BAP have an amazing opportunity for a Regulatory Affairs to join our busy and growing team. The Regulatory Affairs Officer will support the Regulatory Affairs and Pharmacovigilance manager with all associated BAP Pharma regulatory activities. The role will also contribute to the implementation, leading of projects and building of expertise within the Unlicensed Medicines space. *Responsibilities include:-* * Support the Regulatory Affairs and Pharmacovigilance Manager with day to day regulatory responsibilities and build Regulatory Expertise and provide regular update's * Attend relevant team and client meetings with cross-divisional colleagues to provide technical guidance and support for teams as necessary. * Ensuring team members understand the potential opportunities and constraints that the latest legislation/upcoming changes to legislation might create for their commercial activities * Facilitate cross-functional awareness and understanding of regulatory issues. * Providing Regulatory Advice and Information to meet Customer and colleague requests. * Using knowledge of EU/national legislation, guidelines and regulatory environment to provide insightful responses to enquiries. * Advise on matters of compliance, regulatory requirements and regulatory policy * In partnership with operational hubs respond to Regulatory Authority queries and input to aggregate safety reports * Respond to requests from authorities promptly and accurately * Assist in populating and maintaining Regulatory Databases. Responsible for database entry and the document management of regulatory transactions undertaken at local level * Participate in ad hoc and routine QC checking of regulatory data bases * Obtain Authority Approvals for Supply of Unlicensed Medicines * Obtain necessary approvals to import and supply unlicensed medicines for unmet patient needs * Ensure implementation of Good Regulatory Practice (GRP) and Adhere to relevant procedures and practices to ensure GRP is maintained * Maintenance of regulatory activities in line with company procedures. *Requirements*. * Life sciences or chemistry graduate to honours level or equivalent, Master's degree preferred * Previous experience in Regulatory Affairs (Human Medicinal Products) preferred * Member of The Organisation for Professionals in Regulatory Affairs (TOPRA) desirable * Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory Affairs) * Knowledge of the global unlicensed medicines market and or the Pharmaceutical industry is desirable *Competencies* * Excellent communication skills with internal and external partners * Analytical thinking and Ability to prioritise effectively * Results focused with attention to detail * Ability to multitask with excellent written and verbal communication skills * Able to work on own and make decisions independently, where needed This role reports to the Global Medicines Access Director. Overtime may be required from time to time to meet project deadlines. We have a diverse range of employees with different cultures and backgrounds and are committed to diversity and inclusion.
The School requires, as soon as possible, a Security Guard to work as part of small team. A motivated and trustworthy candidate is required to join our Security Team. A flexible approach to working hours is required since there will be a need to cover alternative shifts as necessary. The hours for this position will be on a shift rota from 7.00am to 7.00pm and 7.00pm to 7.00am, over 4 days on and 4 days off, all year round. The salary range for this post is between £21,821per annum and £24,547per annum, dependent on qualifications and experience. C l osing Date: Midday, 30 April 2021 Excellent benefits & training ? superb working environment ? London Stratford 20 mins by train New Hall is committed to increasing representation of Black, Asian and Minority Ethnic backgrounds among staff across all roles and at all levels, to reflect our diverse student population. The School's Equal Opportunities Policy is available on the School's website JOB ID: NH0191 For further details & an application form please visit our website, alternatively, please contact a member of the HR Department. New Hall is committed to safeguarding pupils. There will be an enhanced DBS check prior to appointment.
Apr 16, 2021
Full time
The School requires, as soon as possible, a Security Guard to work as part of small team. A motivated and trustworthy candidate is required to join our Security Team. A flexible approach to working hours is required since there will be a need to cover alternative shifts as necessary. The hours for this position will be on a shift rota from 7.00am to 7.00pm and 7.00pm to 7.00am, over 4 days on and 4 days off, all year round. The salary range for this post is between £21,821per annum and £24,547per annum, dependent on qualifications and experience. C l osing Date: Midday, 30 April 2021 Excellent benefits & training ? superb working environment ? London Stratford 20 mins by train New Hall is committed to increasing representation of Black, Asian and Minority Ethnic backgrounds among staff across all roles and at all levels, to reflect our diverse student population. The School's Equal Opportunities Policy is available on the School's website JOB ID: NH0191 For further details & an application form please visit our website, alternatively, please contact a member of the HR Department. New Hall is committed to safeguarding pupils. There will be an enhanced DBS check prior to appointment.
An excellent opportunity has arisen for a Static Security Officer to join Kingdom Services Group Ltd, working at a manufacturing site in the Shepton Mallett, BA4 area. In return we offer a company award scheme, optional work place pension, career progression and access to a substantial free online training academy for professional development...... click apply for full job details
Apr 16, 2021
Full time
An excellent opportunity has arisen for a Static Security Officer to join Kingdom Services Group Ltd, working at a manufacturing site in the Shepton Mallett, BA4 area. In return we offer a company award scheme, optional work place pension, career progression and access to a substantial free online training academy for professional development...... click apply for full job details
Senior/Principal Regulatory Affairs Specialist We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. If you're a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD is the place to be. Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment - and help get life-changing therapies to patients faster. PPD is seeking a Regulatory Affairs Specialist to join our growing Regulatory Affairs department. This is a fantastic opportunity to further your regulatory career and develop your expertise in this field. In this role you will be a pivotal team member with ideally with regulatory experience. You will provide innovative solutions including global regulatory therapeutic area expertise and client interface to provide strategic regulatory intelligence, guidance and regulatory expertise for product development from preclinical through registration and product optimization. You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients in the provision and marketing of these services. You'll work with the Regulatory Affairs management to perform the day to day operational aspects of the department such as: preparation and assembly of global regulatory submissions unassisted, interacting with sponsors, review and assess clinical trial regulatory documents, review and assess scientific literature. You will also act as prime interface with the sponsors of assigned projects. The following skills are required to be successful in this position: • Experience developing regulatory strategies globally • Experience and knowledge of bid defence meetings • Experience leading global regulatory projects • Client facing experience *Qualifications:* What the role requires you to have: • Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job • Knowledge of the global clinical trials landscape • Proven project management experience, and experience performing effectively in a client facing role Knowledge, Skills and Abilities: • Excellent command of the English language (written and oral) as well as local language where applicable • Excellent attention to detail and quality as well as excellent editorial/proofreading skills • Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments • Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies • Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects • Excellent negotiation skills • Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables • Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines • Excellent analytical, investigative and problem-solving skills • Understanding of budgeting and forecasting At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel. - We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing -We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you. *LI-SH1 As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.
Apr 16, 2021
Full time
Senior/Principal Regulatory Affairs Specialist We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. If you're a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD is the place to be. Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment - and help get life-changing therapies to patients faster. PPD is seeking a Regulatory Affairs Specialist to join our growing Regulatory Affairs department. This is a fantastic opportunity to further your regulatory career and develop your expertise in this field. In this role you will be a pivotal team member with ideally with regulatory experience. You will provide innovative solutions including global regulatory therapeutic area expertise and client interface to provide strategic regulatory intelligence, guidance and regulatory expertise for product development from preclinical through registration and product optimization. You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients in the provision and marketing of these services. You'll work with the Regulatory Affairs management to perform the day to day operational aspects of the department such as: preparation and assembly of global regulatory submissions unassisted, interacting with sponsors, review and assess clinical trial regulatory documents, review and assess scientific literature. You will also act as prime interface with the sponsors of assigned projects. The following skills are required to be successful in this position: • Experience developing regulatory strategies globally • Experience and knowledge of bid defence meetings • Experience leading global regulatory projects • Client facing experience *Qualifications:* What the role requires you to have: • Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job • Knowledge of the global clinical trials landscape • Proven project management experience, and experience performing effectively in a client facing role Knowledge, Skills and Abilities: • Excellent command of the English language (written and oral) as well as local language where applicable • Excellent attention to detail and quality as well as excellent editorial/proofreading skills • Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments • Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies • Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects • Excellent negotiation skills • Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables • Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines • Excellent analytical, investigative and problem-solving skills • Understanding of budgeting and forecasting At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel. - We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing -We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you. *LI-SH1 As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.
Security Officer Speke Job Type: Permanent £24,232 / £27,139 We are currently recruiting for a full time Security officer for our site in Speke to provide high visibility security Static and Mobile guarding at the properties/building and surrounding grounds. Role 1 - Hours of Work: 0730 -1730 - 50 HOURS PER WEEK (Monday to Friday) - £24,232 Role 2 - Hours of Work: 0,1 - 56 HOURS PER WEEK - 3 days, 3 nights, 3 off - £27,139 Principle Accountabilities: Providing high visibility Static Guarding or Mobile Guarding of the property/building and grounds Provide a visible deterrent regarding security issues on the property/building and grounds Provide CCTV monitoring of the perimeter of the property/building and surrounding grounds To have Conflict Resolution training / experience Maintain accurate records and logs of incidents and site visit logs Liaising with Police and other public bodies to ensure a coordinated approach and awareness of local issues Dealing with communications from telephone calls and radio users in a professional manner in accordance with operating procedures Exchanging all necessary information to colleagues during shift change Maintain accurate site contract administration files Candidate Profile Person Specification Security Industry Qualifications - Front line SIA Licence for Security Officers A good Level of interpersonal and customer relationship skills All applicants who are offered employment will be subject to a criminal record check (Disclosure) from the Criminal Records Bureau before the appointment is confirmed. An understanding of a basic Police and other Emergency Services procedures Knowledge of the phonetic alphabet CCTV Monitoring experience Experience of hand-held radio use Future SIA licenses funded First aid certificate
Apr 16, 2021
Full time
Security Officer Speke Job Type: Permanent £24,232 / £27,139 We are currently recruiting for a full time Security officer for our site in Speke to provide high visibility security Static and Mobile guarding at the properties/building and surrounding grounds. Role 1 - Hours of Work: 0730 -1730 - 50 HOURS PER WEEK (Monday to Friday) - £24,232 Role 2 - Hours of Work: 0,1 - 56 HOURS PER WEEK - 3 days, 3 nights, 3 off - £27,139 Principle Accountabilities: Providing high visibility Static Guarding or Mobile Guarding of the property/building and grounds Provide a visible deterrent regarding security issues on the property/building and grounds Provide CCTV monitoring of the perimeter of the property/building and surrounding grounds To have Conflict Resolution training / experience Maintain accurate records and logs of incidents and site visit logs Liaising with Police and other public bodies to ensure a coordinated approach and awareness of local issues Dealing with communications from telephone calls and radio users in a professional manner in accordance with operating procedures Exchanging all necessary information to colleagues during shift change Maintain accurate site contract administration files Candidate Profile Person Specification Security Industry Qualifications - Front line SIA Licence for Security Officers A good Level of interpersonal and customer relationship skills All applicants who are offered employment will be subject to a criminal record check (Disclosure) from the Criminal Records Bureau before the appointment is confirmed. An understanding of a basic Police and other Emergency Services procedures Knowledge of the phonetic alphabet CCTV Monitoring experience Experience of hand-held radio use Future SIA licenses funded First aid certificate
Company Description Culina Logistics is a leading 3rd party UK logistics business specialising in chilled warehousing providing an excellent platform for food and drink manufacturers. We are currently recruiting for a Driver Debriefer to join our Transport team on a permanent basis at our Market Drayton depot...... click apply for full job details
Apr 16, 2021
Full time
Company Description Culina Logistics is a leading 3rd party UK logistics business specialising in chilled warehousing providing an excellent platform for food and drink manufacturers. We are currently recruiting for a Driver Debriefer to join our Transport team on a permanent basis at our Market Drayton depot...... click apply for full job details
PLEASE SUBMIT ENGLISH LANGUAGE RESUMES ONLY *Various Seniority Levels * Home-Based/Remote Based Contract Opportunity *Full Time (FTE 1.0) *6+ month duration Do you prefer flexible work options that allow you to work as a contractor, while also being immersed in the PPD Culture? Apply today to learn more about current and upcoming contractor opportunities through our Functional Service Partnership team. Functional Service Partnership Homepage: Position Summary Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services. *Qualifications:* Essential Functions * Supports the preparation of documentation and submissions under guidance. * Coordinates and manages client deliverables supporting regulatory compliance. * Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects. Assists with project budgeting/forecasting. * Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines. * Assists in business development and pricing of projects for the department. * Evaluates client needs in relationship to overall project timelines, quality and delivery. * Engages other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed. Education and Experience Required * Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). * In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities * Good English language (written and oral) communication skills as well as local language where applicable Good attention to detail and quality as well as editorial/proofreading skills * Good interpersonal skills to work effectively in a team environment * Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies * Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects * Good negotiation skills * Capable of working independently with direction and exercising independent judgment * Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables * Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management * Basic understanding of medical terminology, statistical concepts, and guidelines * Good analytical, investigative and problem-solving skills * Capable of interpreting data PPD is an inclusive equal employment opportunity company. We value all people regardless of background, experience and abilities. PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role * Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. * Able to work upright and stationary for typical working hours. * Ability to use and learn standard office equipment and technology with proficiency. * Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. * May require travel. (Recruiter will provide more details.)
Apr 16, 2021
Full time
PLEASE SUBMIT ENGLISH LANGUAGE RESUMES ONLY *Various Seniority Levels * Home-Based/Remote Based Contract Opportunity *Full Time (FTE 1.0) *6+ month duration Do you prefer flexible work options that allow you to work as a contractor, while also being immersed in the PPD Culture? Apply today to learn more about current and upcoming contractor opportunities through our Functional Service Partnership team. Functional Service Partnership Homepage: Position Summary Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services. *Qualifications:* Essential Functions * Supports the preparation of documentation and submissions under guidance. * Coordinates and manages client deliverables supporting regulatory compliance. * Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects. Assists with project budgeting/forecasting. * Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines. * Assists in business development and pricing of projects for the department. * Evaluates client needs in relationship to overall project timelines, quality and delivery. * Engages other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed. Education and Experience Required * Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). * In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities * Good English language (written and oral) communication skills as well as local language where applicable Good attention to detail and quality as well as editorial/proofreading skills * Good interpersonal skills to work effectively in a team environment * Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies * Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects * Good negotiation skills * Capable of working independently with direction and exercising independent judgment * Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables * Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management * Basic understanding of medical terminology, statistical concepts, and guidelines * Good analytical, investigative and problem-solving skills * Capable of interpreting data PPD is an inclusive equal employment opportunity company. We value all people regardless of background, experience and abilities. PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role * Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. * Able to work upright and stationary for typical working hours. * Ability to use and learn standard office equipment and technology with proficiency. * Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. * May require travel. (Recruiter will provide more details.)
Role Overview Regional Security & Investigations Manager Permanent Field Based (Home site Northampton) Excellent Salary + Car allowance + Benefits Here at Yodel we deliver more than just parcels we deliver a great experience when it comes to your career too...... click apply for full job details
Apr 16, 2021
Full time
Role Overview Regional Security & Investigations Manager Permanent Field Based (Home site Northampton) Excellent Salary + Car allowance + Benefits Here at Yodel we deliver more than just parcels we deliver a great experience when it comes to your career too...... click apply for full job details
Governance Manager Location: King Cross, London, N1C 4BH* Salary: circa £37,000 pro rata Contract: 12 month FTC, part time 0.5 FTE Art Fund is the national fundraising charity for art. We believe that art can make you see, think and feel differently, and through our work we help make art more accessible to as many visitors as possible, wherever they are. We give grants to help museums and galleries acquire works of art for their collections, share them with wide audiences, and support the training and professional development of curators. We are supported by our growing membership of 159,000 through the National Art Pass, as well as the generosity of many trusts, foundations and other individuals. Founded in 1903, Art Fund is a registered charity governed by a Royal Charter that was granted in 1928. Today, we are governed by a Board of 16 Trustees. As well as its legal responsibilities to ensure Art Fund is run in accordance with its charitable objects, the Board also considers applications from museums and galleries for grants towards works of art and other activities. Now, following a recent Board review, and with a new Director in post, Art Fund is at a key moment in its history. We are seeking a part-time Governance Manager to manage Board and committee meetings and the recruitment of new Trustees, and provide governance support and guidance to the Chair of Trustees, Trustees, Director and senior staff. Working with our legal advisor and other senior staff, the role will ensure Art Fund upholds good governance practices and provides all support necessary to Trustees to enable them to discharge their legal responsibilities. A major aspect of the role will be taking a lead on reviewing all the recommendations and implementing agreed changes from the Board review. This role would suit a dedicated charity professional with experience of governance and working with Boards of Trustees, ideally gained in at least two other settings, who is looking to make a real difference to governance policy and practice within an organisation. *The role's location will be our King Cross office (2 Granary Square, London N1C 4BH), with all staff currently working remotely, as will the successful candidate initially. However, once we are back in the office, there would be a reasonable expectation to work from the office, as regularly as everyone else. Closing date: 23rd April 2021 Please click the apply button to be taken to our website where you can find out more information about the role and complete your application. No agencies please.
Apr 16, 2021
Full time
Governance Manager Location: King Cross, London, N1C 4BH* Salary: circa £37,000 pro rata Contract: 12 month FTC, part time 0.5 FTE Art Fund is the national fundraising charity for art. We believe that art can make you see, think and feel differently, and through our work we help make art more accessible to as many visitors as possible, wherever they are. We give grants to help museums and galleries acquire works of art for their collections, share them with wide audiences, and support the training and professional development of curators. We are supported by our growing membership of 159,000 through the National Art Pass, as well as the generosity of many trusts, foundations and other individuals. Founded in 1903, Art Fund is a registered charity governed by a Royal Charter that was granted in 1928. Today, we are governed by a Board of 16 Trustees. As well as its legal responsibilities to ensure Art Fund is run in accordance with its charitable objects, the Board also considers applications from museums and galleries for grants towards works of art and other activities. Now, following a recent Board review, and with a new Director in post, Art Fund is at a key moment in its history. We are seeking a part-time Governance Manager to manage Board and committee meetings and the recruitment of new Trustees, and provide governance support and guidance to the Chair of Trustees, Trustees, Director and senior staff. Working with our legal advisor and other senior staff, the role will ensure Art Fund upholds good governance practices and provides all support necessary to Trustees to enable them to discharge their legal responsibilities. A major aspect of the role will be taking a lead on reviewing all the recommendations and implementing agreed changes from the Board review. This role would suit a dedicated charity professional with experience of governance and working with Boards of Trustees, ideally gained in at least two other settings, who is looking to make a real difference to governance policy and practice within an organisation. *The role's location will be our King Cross office (2 Granary Square, London N1C 4BH), with all staff currently working remotely, as will the successful candidate initially. However, once we are back in the office, there would be a reasonable expectation to work from the office, as regularly as everyone else. Closing date: 23rd April 2021 Please click the apply button to be taken to our website where you can find out more information about the role and complete your application. No agencies please.
Osterna Health & Safety Fire Risk Assessor Full Time Permanent Monday - Friday 37.5 hours Location: South East, Kent or East Sussex Salary £35,000 to £39000 (DOE) + Car Allowance £4,320 + up to 10% productivity bonus. Osterna Limited specialise in Health & Safety compliance in the residential property sector. We are Safe Contractor approved and an NSI approved provider of high quality and fully compliant BAFESP205 Fire Risk Assessments on property throughout the UK. We now require an additional, experienced risk assessor to join our proactive and highly successful team of health and safety professionals. The role of the Health & Safety Fire Risk Assessor: Undertaking Health, Safety and Fire Risk Assessments (PAS 79) in compliance with the Health and Safety at Work etc. act 1974, and Management of Health and Safety at Work Regulations 1999. Risk assessment reports will, in most cases, be confined to the common internal and external areas for high class residential developments. Completed risk assessments will be used by the property managers and directors of the management companies to initiate repairs, or any other procedures required, to ensure the residential common areas remain a safe environment. Skills and Experience required for the Health & Safety Fire Risk Assessor Role The minimum qualifications for this role is the NEBOSH Fire Certificate and NEBOSH National General Certificate. Accuracy and attention to detail within such reports is essential along with a comprehensive knowledge of the current Health and Safety legislation. It is also essential that interested candidates have up to date experience undertaking fire risk assessment work preferably within the public/private residential property sector. A full driving licence is required for this role. Benefits of the Health & Safety Fire Risk Assessor Role: Company funded qualifications and CPD Excellent progression paths and programs 25 days holiday + Bank holidays + Birthday Life Assurance & Pension Company discount portal We have a number of offices throughout the UK and the successful applicant can expect to work from home when compiling reports after visiting Clients' sites. To apply for the Health & Safety Fire Risk Assessor Role please click APPLY. Key Words: Health & Safety, Fire Risk Assessor, Risk Assessments, NEBOSH, Fire, Risk
Apr 16, 2021
Full time
Osterna Health & Safety Fire Risk Assessor Full Time Permanent Monday - Friday 37.5 hours Location: South East, Kent or East Sussex Salary £35,000 to £39000 (DOE) + Car Allowance £4,320 + up to 10% productivity bonus. Osterna Limited specialise in Health & Safety compliance in the residential property sector. We are Safe Contractor approved and an NSI approved provider of high quality and fully compliant BAFESP205 Fire Risk Assessments on property throughout the UK. We now require an additional, experienced risk assessor to join our proactive and highly successful team of health and safety professionals. The role of the Health & Safety Fire Risk Assessor: Undertaking Health, Safety and Fire Risk Assessments (PAS 79) in compliance with the Health and Safety at Work etc. act 1974, and Management of Health and Safety at Work Regulations 1999. Risk assessment reports will, in most cases, be confined to the common internal and external areas for high class residential developments. Completed risk assessments will be used by the property managers and directors of the management companies to initiate repairs, or any other procedures required, to ensure the residential common areas remain a safe environment. Skills and Experience required for the Health & Safety Fire Risk Assessor Role The minimum qualifications for this role is the NEBOSH Fire Certificate and NEBOSH National General Certificate. Accuracy and attention to detail within such reports is essential along with a comprehensive knowledge of the current Health and Safety legislation. It is also essential that interested candidates have up to date experience undertaking fire risk assessment work preferably within the public/private residential property sector. A full driving licence is required for this role. Benefits of the Health & Safety Fire Risk Assessor Role: Company funded qualifications and CPD Excellent progression paths and programs 25 days holiday + Bank holidays + Birthday Life Assurance & Pension Company discount portal We have a number of offices throughout the UK and the successful applicant can expect to work from home when compiling reports after visiting Clients' sites. To apply for the Health & Safety Fire Risk Assessor Role please click APPLY. Key Words: Health & Safety, Fire Risk Assessor, Risk Assessments, NEBOSH, Fire, Risk
*Regulatory Affairs Officer* *Buckinghamshire* *£30,000 salary* If you've got a grounding in Regulatory Affairs gained in the UK and you're interested in your next career move, I'd love to talk with you about an opportunity I'm handling with a genuinely great company. We're working with a specialist life science industry service provider. Historically they've been focused on clinical trials supplies services and have recently moved into packaging and labelling services as well as offering managed / early access services. This company is enjoying significant, sustained growth. They're also enjoying success in international expansions with two sites outside of the UK. The role we're recruiting for sits within a tight knit, high calibre team of people working in a range of diverse roles. With a focus on making sure clients are exceptionally well catered, you'd be working in a regulatory focused role and ensuring that compliance is strictly adhered to while offering creative and practical solutions to problems as they arise. You won't be on your own - there would be great support from the team as a whole and an experienced and supportive RA colleague. *We're looking for someone bright, adaptable and keen to grow as the business does.* I'm not looking for someone with many years' experience for this role. I do have some key, non-negotiable requirements though * You'll have a solid background (expected to be circa 1-2 years experience) in regulatory affairs. * You'll have specific experience of having worked in UK organisations. * And in an ideal world you'll have some experience of managed access though this would be a very nice to have rather than a necessity What our client offers is a great opportunity to enjoy a business that's flourishing and a team that's growing. You'll have great opportunities to learn new skills and more responsibility. Due to the size of the team you can expect to be responsible for tasks that you'd rarely get the opportunity to get involved with in big pharma. *If you meet the requirements and you'd like to know more we'd love to hear from you.*
Apr 16, 2021
Full time
*Regulatory Affairs Officer* *Buckinghamshire* *£30,000 salary* If you've got a grounding in Regulatory Affairs gained in the UK and you're interested in your next career move, I'd love to talk with you about an opportunity I'm handling with a genuinely great company. We're working with a specialist life science industry service provider. Historically they've been focused on clinical trials supplies services and have recently moved into packaging and labelling services as well as offering managed / early access services. This company is enjoying significant, sustained growth. They're also enjoying success in international expansions with two sites outside of the UK. The role we're recruiting for sits within a tight knit, high calibre team of people working in a range of diverse roles. With a focus on making sure clients are exceptionally well catered, you'd be working in a regulatory focused role and ensuring that compliance is strictly adhered to while offering creative and practical solutions to problems as they arise. You won't be on your own - there would be great support from the team as a whole and an experienced and supportive RA colleague. *We're looking for someone bright, adaptable and keen to grow as the business does.* I'm not looking for someone with many years' experience for this role. I do have some key, non-negotiable requirements though * You'll have a solid background (expected to be circa 1-2 years experience) in regulatory affairs. * You'll have specific experience of having worked in UK organisations. * And in an ideal world you'll have some experience of managed access though this would be a very nice to have rather than a necessity What our client offers is a great opportunity to enjoy a business that's flourishing and a team that's growing. You'll have great opportunities to learn new skills and more responsibility. Due to the size of the team you can expect to be responsible for tasks that you'd rarely get the opportunity to get involved with in big pharma. *If you meet the requirements and you'd like to know more we'd love to hear from you.*
9 month maternity cover contract for an experienced Senior Manager, UK Policy and Public Affairs - Inside IR35This is an exciting opportunity to work with one of the leading research-based biopharmaceutical companiesRole overview:An exciting new opportunity has arisen for an exceptional senior healthcare policy communicator to join my clients leading Policy and Public Affairs team and lead work to position the company as a strategic partner for the UK at a critical moment for healthcare and life sciences.This strategic, externally-facing role encompasses a wide range of stakeholder engagement with UK Government, Parliament, the NHS, and Patient Groups and requires a high degree of policy and commercial acumen. The post holder will advance their purpose blueprint by leading the conversation with policy makers and influencers to help ensure that patients are able benefit from new innovation.The post holder will:• Lead the development and delivery of specific Policy and Public Affairs campaigns in support of supporting the NHS to adopt new scientific breakthroughs• Undertake external engagement and build relationships with key government departments, Parliament, the NHS and Patient Groups in support of key strategic priorities, including helping them understand the key access challenges associated with pharmaceutical innovation• Provide deep political and healthcare insights and strategic counsel to business leaders as well as prioritising areas of greatest impact• Be a thought leader, developing new ideas and impactful messaging about the future of UK healthcare and life sciences• Be a trusted adviser to senior business leaders on the life sciences political and policy environmentKey accountabilities:• Deliver a co-ordinated programme of work in collaboration with the wider UK Policy and Public Affairs team• Work closely with all parts of the business, including Global Policy, Business Units, R&D, Health & Value, Medical Affairs, to develop relevant policy frameworks and propositions• Work in close alignment with the External Communications, Global Health and Social Impact, and Patient Advocacy teams to ensure a coherent, truly integrated approach to External Engagement• Work closely with relevant colleagues to develop positions/propositions that support a favourable access environment - short, medium and long-term needs• Build long-term advocacy amongst a diverse range of stakeholders including: Government, NHSE/I, DHSC, Parliamentarians, devolved nations, patient groups, third party policy groups (e.g. think tanks), trade associations (ABPI, BIA, APG, CBI), the academic, clinical and science communities• Ensure UK Management Forum, External Engagement Leadership Team and Global colleagues have timely awareness of policy developments, related positions and activities Skills, Knowledge, Qualifications and Experience• Significant experience in the public policy arena, from a background such as politics, healthcare, civil service, think tank, public affairs agency, life sciences industry• A strong and wide-ranging network of key stakeholders within the UK policy and political landscape, with a high level of understanding of UK political and Parliamentary process• An excellent grasp of the key public policy themes and issues shaping the UK today, with knowledge of the systems and processes in which UK healthcare and life sciences companies operate• Exceptional ability to develops and implement a sophisticated strategic plan that effectively shapes the environment to support a defined purpose• High level of understanding of how to use internal and external communication channels to shape the environment and build/protect organisational reputation.• Demonstrable experience providing strategic counsel to senior political, healthcare or business leaders• An understanding of how to develop public policy positions, with strong analytical and critical thinking skills• Experience working within multi-stakeholder platforms, such as trade associations, to build policy positions and influence change• Understanding of working within a matrix structure and internal paths to influencing. Ability to utilise tools and techniques to facilitate successful working relationships with the wider business.• Experience of commissioning work from public affairs agencies• Pro-active, self-starter able to work with minimal day to day supervision• High impact influencing and negotiating skills• Excellent communications skills; verbal, written, presentation• Maintain strict compliance with all applicable policies and laws, especially those related to interactions with government officialsPlease submit your CV to learn more about this exciting opportunity!
Apr 16, 2021
Full time
9 month maternity cover contract for an experienced Senior Manager, UK Policy and Public Affairs - Inside IR35This is an exciting opportunity to work with one of the leading research-based biopharmaceutical companiesRole overview:An exciting new opportunity has arisen for an exceptional senior healthcare policy communicator to join my clients leading Policy and Public Affairs team and lead work to position the company as a strategic partner for the UK at a critical moment for healthcare and life sciences.This strategic, externally-facing role encompasses a wide range of stakeholder engagement with UK Government, Parliament, the NHS, and Patient Groups and requires a high degree of policy and commercial acumen. The post holder will advance their purpose blueprint by leading the conversation with policy makers and influencers to help ensure that patients are able benefit from new innovation.The post holder will:• Lead the development and delivery of specific Policy and Public Affairs campaigns in support of supporting the NHS to adopt new scientific breakthroughs• Undertake external engagement and build relationships with key government departments, Parliament, the NHS and Patient Groups in support of key strategic priorities, including helping them understand the key access challenges associated with pharmaceutical innovation• Provide deep political and healthcare insights and strategic counsel to business leaders as well as prioritising areas of greatest impact• Be a thought leader, developing new ideas and impactful messaging about the future of UK healthcare and life sciences• Be a trusted adviser to senior business leaders on the life sciences political and policy environmentKey accountabilities:• Deliver a co-ordinated programme of work in collaboration with the wider UK Policy and Public Affairs team• Work closely with all parts of the business, including Global Policy, Business Units, R&D, Health & Value, Medical Affairs, to develop relevant policy frameworks and propositions• Work in close alignment with the External Communications, Global Health and Social Impact, and Patient Advocacy teams to ensure a coherent, truly integrated approach to External Engagement• Work closely with relevant colleagues to develop positions/propositions that support a favourable access environment - short, medium and long-term needs• Build long-term advocacy amongst a diverse range of stakeholders including: Government, NHSE/I, DHSC, Parliamentarians, devolved nations, patient groups, third party policy groups (e.g. think tanks), trade associations (ABPI, BIA, APG, CBI), the academic, clinical and science communities• Ensure UK Management Forum, External Engagement Leadership Team and Global colleagues have timely awareness of policy developments, related positions and activities Skills, Knowledge, Qualifications and Experience• Significant experience in the public policy arena, from a background such as politics, healthcare, civil service, think tank, public affairs agency, life sciences industry• A strong and wide-ranging network of key stakeholders within the UK policy and political landscape, with a high level of understanding of UK political and Parliamentary process• An excellent grasp of the key public policy themes and issues shaping the UK today, with knowledge of the systems and processes in which UK healthcare and life sciences companies operate• Exceptional ability to develops and implement a sophisticated strategic plan that effectively shapes the environment to support a defined purpose• High level of understanding of how to use internal and external communication channels to shape the environment and build/protect organisational reputation.• Demonstrable experience providing strategic counsel to senior political, healthcare or business leaders• An understanding of how to develop public policy positions, with strong analytical and critical thinking skills• Experience working within multi-stakeholder platforms, such as trade associations, to build policy positions and influence change• Understanding of working within a matrix structure and internal paths to influencing. Ability to utilise tools and techniques to facilitate successful working relationships with the wider business.• Experience of commissioning work from public affairs agencies• Pro-active, self-starter able to work with minimal day to day supervision• High impact influencing and negotiating skills• Excellent communications skills; verbal, written, presentation• Maintain strict compliance with all applicable policies and laws, especially those related to interactions with government officialsPlease submit your CV to learn more about this exciting opportunity!
