Job Title: Validation Engineer (Medical Device Manufacturing) Location: Suffolk, UK Company Overview: Join our dynamic client, a leading medical device manufacturing company. They are specialists in developing cutting-edge medical devices that meet the highest quality and regulatory standards. Position Overview: We are seeking a talented Validation Engineer to join our client in Suffolk. The Validation Engineer will play a critical role in ensuring the reliability, safety, and efficacy of our medical devices through comprehensive validation processes. This role will primarily focus on validation activities, encompassing approximately 80% of the workload, with the remaining 20% dedicated to quality-related tasks. Key Responsibilities: Plan, execute, and document validation activities for new product development, process improvements, and equipment qualifications. Develop validation protocols, reports, and procedures in compliance with regulatory requirements and internal quality standards. Perform risk assessments and impact analyses to identify validation requirements and ensure the robustness of validation strategies. Collaborate cross-functionally with R&D, manufacturing, quality assurance, and regulatory affairs teams to ensure alignment and timely completion of validation activities. Provide technical expertise and support during regulatory inspections and audits related to validation processes. Participate in continuous improvement initiatives to enhance validation methodologies, processes, and systems. Contribute to quality management activities, including non-conformance investigations, CAPA implementation, and internal audits. Qualifications: Bachelor's degree in engineering, science, or related field. Master's degree preferred. Previous experience in validation within the medical device industry is essential. Strong understanding of validation principles, methodologies, and regulatory requirements. Proficiency in writing validation protocols, reports, and procedures. Excellent analytical and problem-solving skills with meticulous attention to detail. Effective communication and interpersonal skills, with the ability to collaborate across functional teams. Self-motivated and able to work both independently and as part of a team in a fast-paced environment. Knowledge of quality management systems (e.g., ISO 13485) and statistical analysis techniques is advantageous. Why Join Us: Opportunity to make a meaningful impact on patients' lives by contributing to the development of innovative medical devices. Competitive salary and comprehensive benefits package. Collaborative and supportive work environment with opportunities for professional growth and development. Located in the picturesque county of Suffolk, offering a high quality of life with access to beautiful countryside and coastal areas. If you are passionate about validation engineering and eager to contribute to the advancement of healthcare technology, we invite you to apply for this exciting opportunity. Join our client to deliver life-changing medical solutions. Apply now by submitting your CV or contact Lewis Woollard direct on . JBRP1_UKTJ
Apr 24, 2024
Full time
Job Title: Validation Engineer (Medical Device Manufacturing) Location: Suffolk, UK Company Overview: Join our dynamic client, a leading medical device manufacturing company. They are specialists in developing cutting-edge medical devices that meet the highest quality and regulatory standards. Position Overview: We are seeking a talented Validation Engineer to join our client in Suffolk. The Validation Engineer will play a critical role in ensuring the reliability, safety, and efficacy of our medical devices through comprehensive validation processes. This role will primarily focus on validation activities, encompassing approximately 80% of the workload, with the remaining 20% dedicated to quality-related tasks. Key Responsibilities: Plan, execute, and document validation activities for new product development, process improvements, and equipment qualifications. Develop validation protocols, reports, and procedures in compliance with regulatory requirements and internal quality standards. Perform risk assessments and impact analyses to identify validation requirements and ensure the robustness of validation strategies. Collaborate cross-functionally with R&D, manufacturing, quality assurance, and regulatory affairs teams to ensure alignment and timely completion of validation activities. Provide technical expertise and support during regulatory inspections and audits related to validation processes. Participate in continuous improvement initiatives to enhance validation methodologies, processes, and systems. Contribute to quality management activities, including non-conformance investigations, CAPA implementation, and internal audits. Qualifications: Bachelor's degree in engineering, science, or related field. Master's degree preferred. Previous experience in validation within the medical device industry is essential. Strong understanding of validation principles, methodologies, and regulatory requirements. Proficiency in writing validation protocols, reports, and procedures. Excellent analytical and problem-solving skills with meticulous attention to detail. Effective communication and interpersonal skills, with the ability to collaborate across functional teams. Self-motivated and able to work both independently and as part of a team in a fast-paced environment. Knowledge of quality management systems (e.g., ISO 13485) and statistical analysis techniques is advantageous. Why Join Us: Opportunity to make a meaningful impact on patients' lives by contributing to the development of innovative medical devices. Competitive salary and comprehensive benefits package. Collaborative and supportive work environment with opportunities for professional growth and development. Located in the picturesque county of Suffolk, offering a high quality of life with access to beautiful countryside and coastal areas. If you are passionate about validation engineering and eager to contribute to the advancement of healthcare technology, we invite you to apply for this exciting opportunity. Join our client to deliver life-changing medical solutions. Apply now by submitting your CV or contact Lewis Woollard direct on . JBRP1_UKTJ
Job Title: Validation Engineer (Medical Device Manufacturing) Location: Suffolk, UK Company Overview: Join our dynamic client, a leading medical device manufacturing company. They are specialists in developing cutting-edge medical devices that meet the highest quality and regulatory standards. Position Overview: We are seeking a talented Validation Engineer to join our client in Suffolk. The Validation Engineer will play a critical role in ensuring the reliability, safety, and efficacy of our medical devices through comprehensive validation processes. This role will primarily focus on validation activities, encompassing approximately 80% of the workload, with the remaining 20% dedicated to quality-related tasks. Key Responsibilities: Plan, execute, and document validation activities for new product development, process improvements, and equipment qualifications. Develop validation protocols, reports, and procedures in compliance with regulatory requirements and internal quality standards. Perform risk assessments and impact analyses to identify validation requirements and ensure the robustness of validation strategies. Collaborate cross-functionally with R&D, manufacturing, quality assurance, and regulatory affairs teams to ensure alignment and timely completion of validation activities. Provide technical expertise and support during regulatory inspections and audits related to validation processes. Participate in continuous improvement initiatives to enhance validation methodologies, processes, and systems. Contribute to quality management activities, including non-conformance investigations, CAPA implementation, and internal audits. Qualifications: Bachelor's degree in engineering, science, or related field. Master's degree preferred. Previous experience in validation within the medical device industry is essential. Strong understanding of validation principles, methodologies, and regulatory requirements. Proficiency in writing validation protocols, reports, and procedures. Excellent analytical and problem-solving skills with meticulous attention to detail. Effective communication and interpersonal skills, with the ability to collaborate across functional teams. Self-motivated and able to work both independently and as part of a team in a fast-paced environment. Knowledge of quality management systems (e.g., ISO 13485) and statistical analysis techniques is advantageous. Why Join Us: Opportunity to make a meaningful impact on patients' lives by contributing to the development of innovative medical devices. Competitive salary and comprehensive benefits package. Collaborative and supportive work environment with opportunities for professional growth and development. Located in the picturesque county of Suffolk, offering a high quality of life with access to beautiful countryside and coastal areas. If you are passionate about validation engineering and eager to contribute to the advancement of healthcare technology, we invite you to apply for this exciting opportunity. Join our client to deliver life-changing medical solutions. Apply now by submitting your CV or contact Lewis Woollard direct on (phone number removed).
Apr 23, 2024
Full time
Job Title: Validation Engineer (Medical Device Manufacturing) Location: Suffolk, UK Company Overview: Join our dynamic client, a leading medical device manufacturing company. They are specialists in developing cutting-edge medical devices that meet the highest quality and regulatory standards. Position Overview: We are seeking a talented Validation Engineer to join our client in Suffolk. The Validation Engineer will play a critical role in ensuring the reliability, safety, and efficacy of our medical devices through comprehensive validation processes. This role will primarily focus on validation activities, encompassing approximately 80% of the workload, with the remaining 20% dedicated to quality-related tasks. Key Responsibilities: Plan, execute, and document validation activities for new product development, process improvements, and equipment qualifications. Develop validation protocols, reports, and procedures in compliance with regulatory requirements and internal quality standards. Perform risk assessments and impact analyses to identify validation requirements and ensure the robustness of validation strategies. Collaborate cross-functionally with R&D, manufacturing, quality assurance, and regulatory affairs teams to ensure alignment and timely completion of validation activities. Provide technical expertise and support during regulatory inspections and audits related to validation processes. Participate in continuous improvement initiatives to enhance validation methodologies, processes, and systems. Contribute to quality management activities, including non-conformance investigations, CAPA implementation, and internal audits. Qualifications: Bachelor's degree in engineering, science, or related field. Master's degree preferred. Previous experience in validation within the medical device industry is essential. Strong understanding of validation principles, methodologies, and regulatory requirements. Proficiency in writing validation protocols, reports, and procedures. Excellent analytical and problem-solving skills with meticulous attention to detail. Effective communication and interpersonal skills, with the ability to collaborate across functional teams. Self-motivated and able to work both independently and as part of a team in a fast-paced environment. Knowledge of quality management systems (e.g., ISO 13485) and statistical analysis techniques is advantageous. Why Join Us: Opportunity to make a meaningful impact on patients' lives by contributing to the development of innovative medical devices. Competitive salary and comprehensive benefits package. Collaborative and supportive work environment with opportunities for professional growth and development. Located in the picturesque county of Suffolk, offering a high quality of life with access to beautiful countryside and coastal areas. If you are passionate about validation engineering and eager to contribute to the advancement of healthcare technology, we invite you to apply for this exciting opportunity. Join our client to deliver life-changing medical solutions. Apply now by submitting your CV or contact Lewis Woollard direct on (phone number removed).
Regulatory Affairs Specialist £35,000 to £45,000 per annum + Training + Flexible Working Hours + Progression Holidays + Enhanced Pension Scheme Office Based, Monday to Friday, 9am - 5pm Cheshire Are you looking for a competitively paid position at an industry leading medical device manufacturing company? Are you looking for a role offering extensive training and progression into a senior role in the medical industry? Are you looking to work for a company that prioritises promoting within? Are you looking for a good work-life balance with a role that offers flexible working hours in a family-feel environment? Due to rapid-growth and the securing of large new contracts, my client is looking for an additional Regulatory Affairs Specialist. My client is a well-established medical device manufacturing company based in Cheshire, that offer full training and progression into a Senior Regulatory Affairs Specialist position. The successful candidate will be responsible for providing regulatory expertise in the research, development and marketing of products. The successful candidate will also be responsible for ensuring regulatory guidelines and approvals are obtained within company plans. This is a great opportunity for someone looking to take on more responsibility, broaden their skillset with extensive training, and further their career development in a permanent senior position at a forward-thinking company. FOR FURTHER DETAILS CONTACT - WILLIAM LISLE REF:2360 The Candidate: Regulatory affairs experience Relevant degree in medical, biological, or chemical sciences desirable Lives within a commutable distance of their site The Role: Provide their expertise in the research, development, and marketing of company products Support delivery of the global regulatory programme within the company Training and progression on offer Flexible Working Hours 25 days holiday + Bank Holidays + Extended Christmas Leave Company Pension Scheme Regulatory, affairs, quality, business, strategy, projects, legislation, ISO13485, risk, guidance, advice, guidelines, approvals, research, development, marketing, organisation, Cheshire, Stoke-On-Trent, Whitchurch, Knutsford, Crewe, Sandbach, Nantwich, Wrenbury, Congleton.
Dec 05, 2022
Full time
Regulatory Affairs Specialist £35,000 to £45,000 per annum + Training + Flexible Working Hours + Progression Holidays + Enhanced Pension Scheme Office Based, Monday to Friday, 9am - 5pm Cheshire Are you looking for a competitively paid position at an industry leading medical device manufacturing company? Are you looking for a role offering extensive training and progression into a senior role in the medical industry? Are you looking to work for a company that prioritises promoting within? Are you looking for a good work-life balance with a role that offers flexible working hours in a family-feel environment? Due to rapid-growth and the securing of large new contracts, my client is looking for an additional Regulatory Affairs Specialist. My client is a well-established medical device manufacturing company based in Cheshire, that offer full training and progression into a Senior Regulatory Affairs Specialist position. The successful candidate will be responsible for providing regulatory expertise in the research, development and marketing of products. The successful candidate will also be responsible for ensuring regulatory guidelines and approvals are obtained within company plans. This is a great opportunity for someone looking to take on more responsibility, broaden their skillset with extensive training, and further their career development in a permanent senior position at a forward-thinking company. FOR FURTHER DETAILS CONTACT - WILLIAM LISLE REF:2360 The Candidate: Regulatory affairs experience Relevant degree in medical, biological, or chemical sciences desirable Lives within a commutable distance of their site The Role: Provide their expertise in the research, development, and marketing of company products Support delivery of the global regulatory programme within the company Training and progression on offer Flexible Working Hours 25 days holiday + Bank Holidays + Extended Christmas Leave Company Pension Scheme Regulatory, affairs, quality, business, strategy, projects, legislation, ISO13485, risk, guidance, advice, guidelines, approvals, research, development, marketing, organisation, Cheshire, Stoke-On-Trent, Whitchurch, Knutsford, Crewe, Sandbach, Nantwich, Wrenbury, Congleton.
CK Group are recruiting for a Regulatory Affairs Specialist to join a biopharmaceutical company at their site based in London on a contract basis for 6 or 8 months - there are 2 positions. Hourly Salary: Up to £43.30 PAYE/£56.69 Umbrella depending on experience. Regulatory Affairs Specialist Role: Ensures that marketing authorizations are maintained in compliance with related regulatory areas Develop and implement regulatory strategies identifies regulatory risks, and enables earliest possible approval Ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Information Leaflets, Prescribing Information, packaging material Ensures the correct and proper utilisation of Artwork Management System to generate mock-up artwork and to implement revisions to artwork. Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance. Your Background: BSc. Degree or higher (or equivalent qualifications) in pharmacy or a life-science subject. Comprehension of the fast-evolving EU/UK regulatory procedures especially in light of BREXIT, and EU and UK Medicines Legislation. Exposure to regulatory submissions and working with a Regulatory Authority. Good knowledge of labelling requirements. Experience in managing regulatory projects Meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work. Company: Our client is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. They have an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. Location: This Regulatory Affairs Specialist role will be based at our clients European Business Development and Licensing hub in London. Apply: It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54798 in all correspondence.
Dec 03, 2022
Full time
CK Group are recruiting for a Regulatory Affairs Specialist to join a biopharmaceutical company at their site based in London on a contract basis for 6 or 8 months - there are 2 positions. Hourly Salary: Up to £43.30 PAYE/£56.69 Umbrella depending on experience. Regulatory Affairs Specialist Role: Ensures that marketing authorizations are maintained in compliance with related regulatory areas Develop and implement regulatory strategies identifies regulatory risks, and enables earliest possible approval Ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Information Leaflets, Prescribing Information, packaging material Ensures the correct and proper utilisation of Artwork Management System to generate mock-up artwork and to implement revisions to artwork. Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance. Your Background: BSc. Degree or higher (or equivalent qualifications) in pharmacy or a life-science subject. Comprehension of the fast-evolving EU/UK regulatory procedures especially in light of BREXIT, and EU and UK Medicines Legislation. Exposure to regulatory submissions and working with a Regulatory Authority. Good knowledge of labelling requirements. Experience in managing regulatory projects Meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work. Company: Our client is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. They have an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. Location: This Regulatory Affairs Specialist role will be based at our clients European Business Development and Licensing hub in London. Apply: It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54798 in all correspondence.
Senior Regulatory Affairs Specialist £45,000 to £55,000 per annum + Flexible Working Hours + Progression Holidays + Enhanced Pension Scheme Office Based, Monday to Friday, 9am - 5pm Cheshire Are you looking for a competitively paid position at an industry leading medical device manufacturing company? Are you looking to work for a company that prioritises promoting within? Are you looking for a good click apply for full job details
Dec 02, 2022
Full time
Senior Regulatory Affairs Specialist £45,000 to £55,000 per annum + Flexible Working Hours + Progression Holidays + Enhanced Pension Scheme Office Based, Monday to Friday, 9am - 5pm Cheshire Are you looking for a competitively paid position at an industry leading medical device manufacturing company? Are you looking to work for a company that prioritises promoting within? Are you looking for a good click apply for full job details
Regulatory Affairs Specialist £35,000 to £45,000 per annum + Training + Flexible Working Hours + Progression Holidays + Enhanced Pension Scheme Office Based, Monday to Friday, 9am - 5pm Cheshire Are you looking for a competitively paid position at an industry leading medical device manufacturing company? Are you looking for a role offering extensive training and progression into a senior role in th click apply for full job details
Dec 02, 2022
Full time
Regulatory Affairs Specialist £35,000 to £45,000 per annum + Training + Flexible Working Hours + Progression Holidays + Enhanced Pension Scheme Office Based, Monday to Friday, 9am - 5pm Cheshire Are you looking for a competitively paid position at an industry leading medical device manufacturing company? Are you looking for a role offering extensive training and progression into a senior role in th click apply for full job details
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.Our global team of more than 90,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit our Loughborough office there are 415 employees working in the manufacturing, instruments, equipment and software business units. On our site we ensure safe packing of Fisher Chemical and Thermo Scientific branded products. We also have warehouse and dispatch responsibility (domestic and export, sea & air worldwide) as well as providing a comprehensive analytical capability.The job:We're a looking for a Regulatory Affairs Specialist to join our team of Chemical Regulatory Specialists based in Loughborough, UK, Belgium and the US. You will have two main areas of responsibility. One which is to ensure compliance of the Laboratory Chemicals Division with European and global regulatory requirements and regulations with a great focus on compliance with Reach regulations. You will also provide advice and support to external customers and internal Commercial, Sourcing and Production activities, as required.Please note this role can be based at our Loughborough site or remote in the UK.What will you do?Compliance with registration, authorisation and restriction aspects of REACH legislationLead negotiations with sourcing/purchasing, management and consortia to attain budgets, supply chain understanding and data access for new REACH submission and extensions.Develop and maintain internal volume tracking systems, assisting in improving supply chain flexibility and robustness, conducting internal auditing processes and ensuring sturdy compliance with UK REACH and EU REACH.Responsible for hazard classification of chemical products in accordance with global implementations of GHSResponsible for transport hazard classification of chemical products in accordance with IATA/ICAO, IMDG, ADR, CFR Title 49, TDGAuthoring of safety data sheets for new and existing chemical products in accordance with REACH legislation and other regional implementations of GHSReview of chemical products to identify compliance needs arising from legislation concerning controlled drugs and drug precursors, ozone depleting substances, biocides, chemical weapons, dual-use items and other relevant topicsProvision of advice and support to internal and external customersWho are we looking for?Knowledge, Skills, AbilitiesREACH Experience - in leading negotiations with sourcing/purchasing, management and consortia to attain budgets, supply chain understanding and data access for new submission and extensions.Strong IUCLID 6 knowledge and UK REACH equivalent processes/systemsExperience in a chemical product legislation compliance role, including hazard classification, hazard labelling, safety data sheet authoring, substance registration and other related topicsAwareness of chemical product hazard labelling, safety data sheets and risk assessmentUniversity degree in a chemical disciplineComputer-literate with experience of using word processors, spreadsheets, databases and other software systemsMust be proficient in English languageWhat's in it for you:Work within a very close teamGood pension scheme & flexible benefitsAn opportunity for career developmentAbout us:With Thermo Fisher Scientific, it's not just a career. It's a chance to realise your best - professionally and personally.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of sex, transgender identity or expression, ethnicity, religion or other belief, disability, sexual orientation or age.Apply today!
Dec 06, 2021
Full time
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.Our global team of more than 90,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit our Loughborough office there are 415 employees working in the manufacturing, instruments, equipment and software business units. On our site we ensure safe packing of Fisher Chemical and Thermo Scientific branded products. We also have warehouse and dispatch responsibility (domestic and export, sea & air worldwide) as well as providing a comprehensive analytical capability.The job:We're a looking for a Regulatory Affairs Specialist to join our team of Chemical Regulatory Specialists based in Loughborough, UK, Belgium and the US. You will have two main areas of responsibility. One which is to ensure compliance of the Laboratory Chemicals Division with European and global regulatory requirements and regulations with a great focus on compliance with Reach regulations. You will also provide advice and support to external customers and internal Commercial, Sourcing and Production activities, as required.Please note this role can be based at our Loughborough site or remote in the UK.What will you do?Compliance with registration, authorisation and restriction aspects of REACH legislationLead negotiations with sourcing/purchasing, management and consortia to attain budgets, supply chain understanding and data access for new REACH submission and extensions.Develop and maintain internal volume tracking systems, assisting in improving supply chain flexibility and robustness, conducting internal auditing processes and ensuring sturdy compliance with UK REACH and EU REACH.Responsible for hazard classification of chemical products in accordance with global implementations of GHSResponsible for transport hazard classification of chemical products in accordance with IATA/ICAO, IMDG, ADR, CFR Title 49, TDGAuthoring of safety data sheets for new and existing chemical products in accordance with REACH legislation and other regional implementations of GHSReview of chemical products to identify compliance needs arising from legislation concerning controlled drugs and drug precursors, ozone depleting substances, biocides, chemical weapons, dual-use items and other relevant topicsProvision of advice and support to internal and external customersWho are we looking for?Knowledge, Skills, AbilitiesREACH Experience - in leading negotiations with sourcing/purchasing, management and consortia to attain budgets, supply chain understanding and data access for new submission and extensions.Strong IUCLID 6 knowledge and UK REACH equivalent processes/systemsExperience in a chemical product legislation compliance role, including hazard classification, hazard labelling, safety data sheet authoring, substance registration and other related topicsAwareness of chemical product hazard labelling, safety data sheets and risk assessmentUniversity degree in a chemical disciplineComputer-literate with experience of using word processors, spreadsheets, databases and other software systemsMust be proficient in English languageWhat's in it for you:Work within a very close teamGood pension scheme & flexible benefitsAn opportunity for career developmentAbout us:With Thermo Fisher Scientific, it's not just a career. It's a chance to realise your best - professionally and personally.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of sex, transgender identity or expression, ethnicity, religion or other belief, disability, sexual orientation or age.Apply today!
Our client is part of a group of global medical device companies. The brand specialise in sterile single-use surgical instruments, priding themselves on developing new and innovative products that are used for a variety of therapy areas. Reporting to the Head of Regulatory Affairs and based in Swansea there is some flexible working on offer if required for the chosen candidate. Role: The Regulatory Affairs Manager will be responsible for management of a team of technical file writers who share responsibility for all technical files for the site. Co-ordinate work undertaken by other specialists, clinical writer (s) and biocompatibility consultant etc. Act as the on-site expert on all regulatory matters, providing advise, guidance to QA, Manufacturing and other managers Create and maintain technical files to MDD requirements The Regulatory Affairs Manager will update Technical files to MDR Create and maintain technical documentation to US FDA requirements when needed Update Technical files to meet new products/modifications updates to technical documentation and supplier changes Oversee overseas registrations of products Review of and approve documentation and document change orders Assist in preparing responses to regulatory authorities' Write supplier agreements The Regulatory Affairs Manager will also be responsible for the RA plans for the design and development teams to support Global markets Assist and ensure devices are registered in EU/FDA and UK MHRA databases Stay abreast of regulatory procedures and changes in regulatory climate Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance and addressing any issues arising. Qualifications & Skills: Ideally degree level education or practical experience in Regulatory Affairs Medical devices to MDD/MDR standard EU Medical Device regulations, harmonised standards and associated non-harmonised standards, Working Knowledge of US FDA requirements Knowledge of MDSAP desirable but not essential To find out more about Real please visit Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales
Dec 05, 2021
Full time
Our client is part of a group of global medical device companies. The brand specialise in sterile single-use surgical instruments, priding themselves on developing new and innovative products that are used for a variety of therapy areas. Reporting to the Head of Regulatory Affairs and based in Swansea there is some flexible working on offer if required for the chosen candidate. Role: The Regulatory Affairs Manager will be responsible for management of a team of technical file writers who share responsibility for all technical files for the site. Co-ordinate work undertaken by other specialists, clinical writer (s) and biocompatibility consultant etc. Act as the on-site expert on all regulatory matters, providing advise, guidance to QA, Manufacturing and other managers Create and maintain technical files to MDD requirements The Regulatory Affairs Manager will update Technical files to MDR Create and maintain technical documentation to US FDA requirements when needed Update Technical files to meet new products/modifications updates to technical documentation and supplier changes Oversee overseas registrations of products Review of and approve documentation and document change orders Assist in preparing responses to regulatory authorities' Write supplier agreements The Regulatory Affairs Manager will also be responsible for the RA plans for the design and development teams to support Global markets Assist and ensure devices are registered in EU/FDA and UK MHRA databases Stay abreast of regulatory procedures and changes in regulatory climate Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance and addressing any issues arising. Qualifications & Skills: Ideally degree level education or practical experience in Regulatory Affairs Medical devices to MDD/MDR standard EU Medical Device regulations, harmonised standards and associated non-harmonised standards, Working Knowledge of US FDA requirements Knowledge of MDSAP desirable but not essential To find out more about Real please visit Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales
Regulatory Affairs Regulatory Specialist Commercial Strategy Your new company This a flagship business within the NHS which manufactures and distributes terminally sterilised injectables for the secondary care market in the UK and worldwide. They Opened a new manufacturing site in 2017 supported by a \u00A326m investment. They aim to double the size of the business in the next 4-5 years. This is a semi-autonomous business unit and has its own Management Board. Due to projects and expansion. They are looking for Regulatory Affairs Specialist. Your new role This is an exciting flagship business to work, with a fast pace environment. Responsible for the generation & submission of regulatory documentation to regulatory agencies. Maintain Marketing Authorisations in line with the commercial strategy to support the current & future business targets. Responsible for maintaining the post market product regulatory lifecycle. There office is in Torbay in the UK. The team works closely together and creates a supportive, flexible, happy environment that is committed to delivering quality outcomes against targets. What you'll need to succeed Degree in relevant subject area or equivalent experience 2 years+ experience of working within the pharmaceutical industry What you'll get in return Flexible working options available. Competitive Market Salary and Fully remote role with 1 day a month attendance required in the office. What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
Dec 05, 2021
Full time
Regulatory Affairs Regulatory Specialist Commercial Strategy Your new company This a flagship business within the NHS which manufactures and distributes terminally sterilised injectables for the secondary care market in the UK and worldwide. They Opened a new manufacturing site in 2017 supported by a \u00A326m investment. They aim to double the size of the business in the next 4-5 years. This is a semi-autonomous business unit and has its own Management Board. Due to projects and expansion. They are looking for Regulatory Affairs Specialist. Your new role This is an exciting flagship business to work, with a fast pace environment. Responsible for the generation & submission of regulatory documentation to regulatory agencies. Maintain Marketing Authorisations in line with the commercial strategy to support the current & future business targets. Responsible for maintaining the post market product regulatory lifecycle. There office is in Torbay in the UK. The team works closely together and creates a supportive, flexible, happy environment that is committed to delivering quality outcomes against targets. What you'll need to succeed Degree in relevant subject area or equivalent experience 2 years+ experience of working within the pharmaceutical industry What you'll get in return Flexible working options available. Competitive Market Salary and Fully remote role with 1 day a month attendance required in the office. What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
We have an exciting opportunity available as a Head of Manufacturing/CMC at a Rare Disease Biotechnology company based in the North of England. This is a fantastic opportunity for an experienced sterile manufacturing expert to join a small innovate Biotech in a senior position with complete control over the creation of a sterile cleanroom. The job description and responsibilities for this position are currently being written. Please apply and get in contact to discuss in detail. *Responsibilities at a glance* Responsible for creation of a brand new 600m2 GMP clean room ready for the middle of next year. It will be the responsibility of the Head of Manufacturing to design, order equipment and set up the state-of-the-art facility. This person will then be expected to prepare for inspections and hire additional staff for the manufacturing/CMC team and take a leadership position of this group. This hire will also be relied on as an expert to guide the development of company products from research into the clinic. *Requirements * * Significant experience in a hands-on CMC/Manufacturing role in a GMP environment * Experience leading teams managing a team of approximately 4-10 people * Strong understanding of relevant industry regulatory requirements Following your application Simon Trebilcock, a specialist Scientific Recruiter with over 7 years' experience recruiting in the scientific field will discuss the opportunity with you in detail. Eager to both give insight into the future of the opportunity and company but also learn more about your vision for your career growth. If desired Simon would look to remain in contact to alert you to opportunities which align with your interest and career plans. This position has been highly popular, and it is likely that it will close prematurely. We recommend applying as soon as possible to avoid disappointment. Please click 'apply' or contact Simon Trebilcock for any further information Email - [](mailto:) Telephone - (0). *About Planet Pharma* Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering. Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing. We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. []()
Dec 05, 2021
Full time
We have an exciting opportunity available as a Head of Manufacturing/CMC at a Rare Disease Biotechnology company based in the North of England. This is a fantastic opportunity for an experienced sterile manufacturing expert to join a small innovate Biotech in a senior position with complete control over the creation of a sterile cleanroom. The job description and responsibilities for this position are currently being written. Please apply and get in contact to discuss in detail. *Responsibilities at a glance* Responsible for creation of a brand new 600m2 GMP clean room ready for the middle of next year. It will be the responsibility of the Head of Manufacturing to design, order equipment and set up the state-of-the-art facility. This person will then be expected to prepare for inspections and hire additional staff for the manufacturing/CMC team and take a leadership position of this group. This hire will also be relied on as an expert to guide the development of company products from research into the clinic. *Requirements * * Significant experience in a hands-on CMC/Manufacturing role in a GMP environment * Experience leading teams managing a team of approximately 4-10 people * Strong understanding of relevant industry regulatory requirements Following your application Simon Trebilcock, a specialist Scientific Recruiter with over 7 years' experience recruiting in the scientific field will discuss the opportunity with you in detail. Eager to both give insight into the future of the opportunity and company but also learn more about your vision for your career growth. If desired Simon would look to remain in contact to alert you to opportunities which align with your interest and career plans. This position has been highly popular, and it is likely that it will close prematurely. We recommend applying as soon as possible to avoid disappointment. Please click 'apply' or contact Simon Trebilcock for any further information Email - [](mailto:) Telephone - (0). *About Planet Pharma* Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering. Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing. We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. []()
We have an exciting opportunity available as a Head of Manufacturing/CMC at a Rare Disease Biotechnology company based in the North of England. This is a fantastic opportunity for an experienced sterile manufacturing expert to join a small innovate Biotech in a senior position with complete control over the creation of a sterile cleanroom. The job description and responsibilities for this position are currently being written. Please apply and get in contact to discuss in detail. *Responsibilities at a glance* Responsible for creation of a brand new 600m2 GMP clean room ready for the middle of next year. It will be the responsibility of the Head of Manufacturing to design, order equipment and set up the state-of-the-art facility. This person will then be expected to prepare for inspections and hire additional staff for the manufacturing/CMC team and take a leadership position of this group. This hire will also be relied on as an expert to guide the development of company products from research into the clinic. *Requirements * * Significant experience in a hands-on CMC/Manufacturing role in a GMP environment * Experience leading teams managing a team of approximately 4-10 people * Strong understanding of relevant industry regulatory requirements Following your application Simon Trebilcock, a specialist Scientific Recruiter with over 7 years' experience recruiting in the scientific field will discuss the opportunity with you in detail. Eager to both give insight into the future of the opportunity and company but also learn more about your vision for your career growth. If desired Simon would look to remain in contact to alert you to opportunities which align with your interest and career plans. This position has been highly popular, and it is likely that it will close prematurely. We recommend applying as soon as possible to avoid disappointment. Please click 'apply' or contact Simon Trebilcock for any further information Email - [](mailto:) Telephone - (0). *About Planet Pharma* Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering. Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing. We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. []()
Dec 04, 2021
Full time
We have an exciting opportunity available as a Head of Manufacturing/CMC at a Rare Disease Biotechnology company based in the North of England. This is a fantastic opportunity for an experienced sterile manufacturing expert to join a small innovate Biotech in a senior position with complete control over the creation of a sterile cleanroom. The job description and responsibilities for this position are currently being written. Please apply and get in contact to discuss in detail. *Responsibilities at a glance* Responsible for creation of a brand new 600m2 GMP clean room ready for the middle of next year. It will be the responsibility of the Head of Manufacturing to design, order equipment and set up the state-of-the-art facility. This person will then be expected to prepare for inspections and hire additional staff for the manufacturing/CMC team and take a leadership position of this group. This hire will also be relied on as an expert to guide the development of company products from research into the clinic. *Requirements * * Significant experience in a hands-on CMC/Manufacturing role in a GMP environment * Experience leading teams managing a team of approximately 4-10 people * Strong understanding of relevant industry regulatory requirements Following your application Simon Trebilcock, a specialist Scientific Recruiter with over 7 years' experience recruiting in the scientific field will discuss the opportunity with you in detail. Eager to both give insight into the future of the opportunity and company but also learn more about your vision for your career growth. If desired Simon would look to remain in contact to alert you to opportunities which align with your interest and career plans. This position has been highly popular, and it is likely that it will close prematurely. We recommend applying as soon as possible to avoid disappointment. Please click 'apply' or contact Simon Trebilcock for any further information Email - [](mailto:) Telephone - (0). *About Planet Pharma* Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering. Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing. We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. []()
Our client is part of a group of global medical device companies. The brand specialise in sterile single-use surgical instruments, priding themselves on developing new and innovative products that are used for a variety of therapy areas. Reporting to the Head of Regulatory Affairs and based in Swansea there is some flexible working on offer if required for the chosen candidate. Role: The Regulatory Affairs Manager will be responsible for management of a team of technical file writers who share responsibility for all technical files for the site. Co-ordinate work undertaken by other specialists, clinical writer (s) and biocompatibility consultant etc. Act as the on-site expert on all regulatory matters, providing advise, guidance to QA, Manufacturing and other managers Create and maintain technical files to MDD requirements The Regulatory Affairs Manager will update Technical files to MDR Create and maintain technical documentation to US FDA requirements when needed Update Technical files to meet new products/modifications updates to technical documentation and supplier changes Oversee overseas registrations of products Review of and approve documentation and document change orders Assist in preparing responses to regulatory authorities' Write supplier agreements The Regulatory Affairs Manager will also be responsible for the RA plans for the design and development teams to support Global markets Assist and ensure devices are registered in EU/FDA and UK MHRA databases Stay abreast of regulatory procedures and changes in regulatory climate Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance and addressing any issues arising. Qualifications & Skills: Ideally degree level education or practical experience in Regulatory Affairs Medical devices to MDD/MDR standard EU Medical Device regulations, harmonised standards and associated non-harmonised standards Working Knowledge of US FDA requirements Knowledge of MDSAP desirable but not essential Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales
Dec 03, 2021
Full time
Our client is part of a group of global medical device companies. The brand specialise in sterile single-use surgical instruments, priding themselves on developing new and innovative products that are used for a variety of therapy areas. Reporting to the Head of Regulatory Affairs and based in Swansea there is some flexible working on offer if required for the chosen candidate. Role: The Regulatory Affairs Manager will be responsible for management of a team of technical file writers who share responsibility for all technical files for the site. Co-ordinate work undertaken by other specialists, clinical writer (s) and biocompatibility consultant etc. Act as the on-site expert on all regulatory matters, providing advise, guidance to QA, Manufacturing and other managers Create and maintain technical files to MDD requirements The Regulatory Affairs Manager will update Technical files to MDR Create and maintain technical documentation to US FDA requirements when needed Update Technical files to meet new products/modifications updates to technical documentation and supplier changes Oversee overseas registrations of products Review of and approve documentation and document change orders Assist in preparing responses to regulatory authorities' Write supplier agreements The Regulatory Affairs Manager will also be responsible for the RA plans for the design and development teams to support Global markets Assist and ensure devices are registered in EU/FDA and UK MHRA databases Stay abreast of regulatory procedures and changes in regulatory climate Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance and addressing any issues arising. Qualifications & Skills: Ideally degree level education or practical experience in Regulatory Affairs Medical devices to MDD/MDR standard EU Medical Device regulations, harmonised standards and associated non-harmonised standards Working Knowledge of US FDA requirements Knowledge of MDSAP desirable but not essential Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales
The Role Creation and management of technical files of all legal manufactured products Creation of QA/RA plans for the design and development teams to support Global markets up to the formation of the standard dossier. Creation and maintenance of harmonized standards compliance plans QMS updates required for higher risk IVD's such as PMA and WHO pre-qualification programme activities. Review and approval of change requests for regulatory impact assessment Creation of process for the management of approval of global marketing collaterals and localization process Review and approval of marketing collaterals About You We are looking for a highly motivated individual with exceptional attention to detail and high level of skills in communication, along with the following skills and experience: Knowledge and experience of working to the appropriate quality and regulatory standards including ISO 13485, ISO 14971, FDA 21CFR part 820, IVD 98/79/EC/IVDR Knowledge of Adverse event reporting in clinical environment Experience and knowledge of vertical and horizontal standards for IVD medical device instruments and assays in the point of care. Demonstration of good problem solving abilities Influence internal project team and external parties to maximize success opportunities Excellent organizational skills Experience of working in an IVD or medical device design and manufacturing environment Detailed knowledge of post market regulatory activities including FSCA, incident reporting Development and writing of CE marking technical files Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales
Dec 02, 2021
Full time
The Role Creation and management of technical files of all legal manufactured products Creation of QA/RA plans for the design and development teams to support Global markets up to the formation of the standard dossier. Creation and maintenance of harmonized standards compliance plans QMS updates required for higher risk IVD's such as PMA and WHO pre-qualification programme activities. Review and approval of change requests for regulatory impact assessment Creation of process for the management of approval of global marketing collaterals and localization process Review and approval of marketing collaterals About You We are looking for a highly motivated individual with exceptional attention to detail and high level of skills in communication, along with the following skills and experience: Knowledge and experience of working to the appropriate quality and regulatory standards including ISO 13485, ISO 14971, FDA 21CFR part 820, IVD 98/79/EC/IVDR Knowledge of Adverse event reporting in clinical environment Experience and knowledge of vertical and horizontal standards for IVD medical device instruments and assays in the point of care. Demonstration of good problem solving abilities Influence internal project team and external parties to maximize success opportunities Excellent organizational skills Experience of working in an IVD or medical device design and manufacturing environment Detailed knowledge of post market regulatory activities including FSCA, incident reporting Development and writing of CE marking technical files Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales
Our Client develops and distributes licensed and unlicensed medicinal products. They use proprietary drug delivery technologies to reformulate existing medicines, to create bespoke products to address the unmet medical needs of patients with niche diseases. The strategic intent of our client is to develop and register more products as licensed medicines, applying for Marketing Authorisation's whenever commercially justified. Our Client uses trusted contract development and manufacturing partners to produce their medicines, which they distribute in the UK and overseas via distribution partners. They are committed to the highest quality standards in their business, and to operating within the Medicines and Healthcare products Regulatory Agency (MHRA) regulatory framework especially to ensure compliance with Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP). They are now seeking a Regulatory Affairs Specialist . This position is a full-time permanent role and will report to the Regulatory Affairs Manager.The position will be office based in Surrey with occasional travel. Purpose of Job Take responsibility for managing regulatory aspects of product development projects intended for inclusion into Marketing Authorisation Applications and lifecycle management of approved Marketing Authorisations. This includes preparing and maintaining dossier documentation, CMC documentation, licence variations and product information in the UK, Europe or globally. Key Areas of Responsibility Develop the technical quality data, non-clinical and clinical data of selected product to eCTD standard to support MAA: Identify the weaknesses and gaps in the quality areas of the developed drug products, this may include the drug substance, drug product, non-clinical and clinical areas of the selected products Take responsibility for preparing and maintaining dossier and CMC documentation Manage the life-cycle of products in the licenced territories (UK, Australia and Europe) Prepare and review CMC documentation for Modules 1, 2 and 3 Prepare and submit new Marketing Authorisation Applications (MAAs) Provide expert strategy advice on regulatory pathways, which may be complex Liaise with regulatory groups, manufacturing facilities and external contractors to ensure the relevant documentation is available Manage regulatory aspects of product development projects for licenced products: Work in collaboration with internal stakeholders to identify and design regulatory and technically viable product development opportunities for subsequent licence applications Identify and recommend the most appropriate regulatory strategy for each project Working with the Product Development team to identify the appropriate regulatory resources (financial, expertise) required for each project and ensure that these are allocated within the Company and the contract development, manufacturing and regulatory partner Report on project progress, advising stakeholders of challenges in a timely manner Complete Company documentation in a timely and accurate manner: Ensure primary documentation at the external partner companies is prepared and signed off in advance of a decision being implemented Accurately document agreed activities with a clear audit trail Complete QMS and financial management documentation in a timely manner Prepare and send purchase orders in advance of work being undertaken by contract manufacturers and suppliers General Work within the Company procedures and processes To keep up to date with regulatory and industry standards and apply to current projects Travel to and spend time as required at supplier, contract manufacturer or other potential partner sites Qualifications / Experience BSc or equivalent science-based degree Prior experience of a Regulatory Affairs role, ideally with MAA experience and life-cycle management Ability to prepare, review and maintain product information and CMC documentation Experience of product development and new applications In depth understanding of the different application routes Post marketing experience including variations, renewals and labelling Experience developing and implementing regulatory strategies Preferably experience in writing / reviewing of IMPD's/MAA's Ability to establish and maintain effective working relationships with internal and external stakeholders Strong written and verbal communication skills In return our client is offering a basic salary of c£45,000 per annum basic (salary is negotiable dependant on experience) plus benefits for the successful Candidate Please send your C.V to Lorraine Roger, Director at Atom Recruitment Ltd.
Dec 02, 2021
Full time
Our Client develops and distributes licensed and unlicensed medicinal products. They use proprietary drug delivery technologies to reformulate existing medicines, to create bespoke products to address the unmet medical needs of patients with niche diseases. The strategic intent of our client is to develop and register more products as licensed medicines, applying for Marketing Authorisation's whenever commercially justified. Our Client uses trusted contract development and manufacturing partners to produce their medicines, which they distribute in the UK and overseas via distribution partners. They are committed to the highest quality standards in their business, and to operating within the Medicines and Healthcare products Regulatory Agency (MHRA) regulatory framework especially to ensure compliance with Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP). They are now seeking a Regulatory Affairs Specialist . This position is a full-time permanent role and will report to the Regulatory Affairs Manager.The position will be office based in Surrey with occasional travel. Purpose of Job Take responsibility for managing regulatory aspects of product development projects intended for inclusion into Marketing Authorisation Applications and lifecycle management of approved Marketing Authorisations. This includes preparing and maintaining dossier documentation, CMC documentation, licence variations and product information in the UK, Europe or globally. Key Areas of Responsibility Develop the technical quality data, non-clinical and clinical data of selected product to eCTD standard to support MAA: Identify the weaknesses and gaps in the quality areas of the developed drug products, this may include the drug substance, drug product, non-clinical and clinical areas of the selected products Take responsibility for preparing and maintaining dossier and CMC documentation Manage the life-cycle of products in the licenced territories (UK, Australia and Europe) Prepare and review CMC documentation for Modules 1, 2 and 3 Prepare and submit new Marketing Authorisation Applications (MAAs) Provide expert strategy advice on regulatory pathways, which may be complex Liaise with regulatory groups, manufacturing facilities and external contractors to ensure the relevant documentation is available Manage regulatory aspects of product development projects for licenced products: Work in collaboration with internal stakeholders to identify and design regulatory and technically viable product development opportunities for subsequent licence applications Identify and recommend the most appropriate regulatory strategy for each project Working with the Product Development team to identify the appropriate regulatory resources (financial, expertise) required for each project and ensure that these are allocated within the Company and the contract development, manufacturing and regulatory partner Report on project progress, advising stakeholders of challenges in a timely manner Complete Company documentation in a timely and accurate manner: Ensure primary documentation at the external partner companies is prepared and signed off in advance of a decision being implemented Accurately document agreed activities with a clear audit trail Complete QMS and financial management documentation in a timely manner Prepare and send purchase orders in advance of work being undertaken by contract manufacturers and suppliers General Work within the Company procedures and processes To keep up to date with regulatory and industry standards and apply to current projects Travel to and spend time as required at supplier, contract manufacturer or other potential partner sites Qualifications / Experience BSc or equivalent science-based degree Prior experience of a Regulatory Affairs role, ideally with MAA experience and life-cycle management Ability to prepare, review and maintain product information and CMC documentation Experience of product development and new applications In depth understanding of the different application routes Post marketing experience including variations, renewals and labelling Experience developing and implementing regulatory strategies Preferably experience in writing / reviewing of IMPD's/MAA's Ability to establish and maintain effective working relationships with internal and external stakeholders Strong written and verbal communication skills In return our client is offering a basic salary of c£45,000 per annum basic (salary is negotiable dependant on experience) plus benefits for the successful Candidate Please send your C.V to Lorraine Roger, Director at Atom Recruitment Ltd.
This is an exciting opportunity to join a global leading Clinical Research organisation within their dynamic CMC team. The role will require you to provide CMC subject matter expertise to a leading pharmaceutical client giving you excellent career development opportunities including progression opportunities within the company. *In this role you will be required to:* * Acts as a Regulatory Team Leader on complex projects, which may include technical writing. * Prepares and review regulatory documentation in area of expertise, as appropriate. * Establishes relationships with many customers as well as working with cross functional teams and stakeholders * Acts as a subject matter expert for Regulatory Chemistry, Manufacturing and Controls *We are looking to speak to candidates with:* * At least 3 years Regulatory CMC experience including post marketing submissions * Experience reviewing and approving change request controls * Experience taking ownership for assigned products * A life science degree (Masters preferred) * Experience working cross functionally and managing multiple stakeholders This is an excellent opportunity to join a global leading company who make a positive impact on millions of people around the world. This is a permanent role which will give you the chance to become a valued member of the team and eventually progress into a leadership position. This role can be fully remote based from anywhere in Europe and is offering a competitive salary as well as an attractive benefits package. We are looking for people to join immediately so apply today! "Regulatory" "Regulatory Affairs" "CMC" "Regulatory CMC" "Regulatory
Dec 02, 2021
Full time
This is an exciting opportunity to join a global leading Clinical Research organisation within their dynamic CMC team. The role will require you to provide CMC subject matter expertise to a leading pharmaceutical client giving you excellent career development opportunities including progression opportunities within the company. *In this role you will be required to:* * Acts as a Regulatory Team Leader on complex projects, which may include technical writing. * Prepares and review regulatory documentation in area of expertise, as appropriate. * Establishes relationships with many customers as well as working with cross functional teams and stakeholders * Acts as a subject matter expert for Regulatory Chemistry, Manufacturing and Controls *We are looking to speak to candidates with:* * At least 3 years Regulatory CMC experience including post marketing submissions * Experience reviewing and approving change request controls * Experience taking ownership for assigned products * A life science degree (Masters preferred) * Experience working cross functionally and managing multiple stakeholders This is an excellent opportunity to join a global leading company who make a positive impact on millions of people around the world. This is a permanent role which will give you the chance to become a valued member of the team and eventually progress into a leadership position. This role can be fully remote based from anywhere in Europe and is offering a competitive salary as well as an attractive benefits package. We are looking for people to join immediately so apply today! "Regulatory" "Regulatory Affairs" "CMC" "Regulatory CMC" "Regulatory
Hobson Prior are currently working with a top pharmaceutical organisation who are focused on the development, manufacturing and commercialising of medicines that will make a real transformation to patients and their family's lives. Our client is seeking a Regulatory Affairs Specialist to join them on a permanent basis. Please note that to be considered for this role you must have the right to work ...... click apply for full job details
Nov 30, 2021
Full time
Hobson Prior are currently working with a top pharmaceutical organisation who are focused on the development, manufacturing and commercialising of medicines that will make a real transformation to patients and their family's lives. Our client is seeking a Regulatory Affairs Specialist to join them on a permanent basis. Please note that to be considered for this role you must have the right to work ...... click apply for full job details