Are you an experienced regulatory affairs professional looking for a new opportunity? We are currently seeking a talented Regulatory Affairs Consultant to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European locations. As the Regulatory Affairs Consultant you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological products. Primary Tasks & Responsibilities: Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports. Assess change controls and provide regulatory assessments of quality changes in production and quality control. Review study reports from the quality control and production departments to ensure compliance with regulatory requirements. Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies. Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities. Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions. Identify, escalate, and mitigate risks associated with regulatory procedures and activities. Experience and Knowledge Requirements: University-level education, preferably in Life Sciences, or equivalent by experience. Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry. Strong understanding of CMC and post-approval regulatory requirements. Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations. Knowledge of biological processes. Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification/validation principles. Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued. Team spirit, flexibility, accountability, and organizational skills. Fluent in English (written and spoken).
Jul 26, 2025
Full time
Are you an experienced regulatory affairs professional looking for a new opportunity? We are currently seeking a talented Regulatory Affairs Consultant to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European locations. As the Regulatory Affairs Consultant you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological products. Primary Tasks & Responsibilities: Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports. Assess change controls and provide regulatory assessments of quality changes in production and quality control. Review study reports from the quality control and production departments to ensure compliance with regulatory requirements. Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies. Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities. Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions. Identify, escalate, and mitigate risks associated with regulatory procedures and activities. Experience and Knowledge Requirements: University-level education, preferably in Life Sciences, or equivalent by experience. Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry. Strong understanding of CMC and post-approval regulatory requirements. Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations. Knowledge of biological processes. Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification/validation principles. Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued. Team spirit, flexibility, accountability, and organizational skills. Fluent in English (written and spoken).
Are you an experienced regulatory affairs professional looking for a new opportunity? We are currently seeking a talented Regulatory Affairs Consultant to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European locations. As the Regulatory Affairs Consultant you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological products. Primary Tasks & Responsibilities: Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports. Assess change controls and provide regulatory assessments of quality changes in production and quality control. Review study reports from the quality control and production departments to ensure compliance with regulatory requirements. Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies. Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities. Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions. Identify, escalate, and mitigate risks associated with regulatory procedures and activities. Experience and Knowledge Requirements: University-level education, preferably in Life Sciences, or equivalent by experience. Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry. Strong understanding of CMC and post-approval regulatory requirements. Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations. Knowledge of biological processes. Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification/validation principles. Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued. Team spirit, flexibility, accountability, and organizational skills. Fluent in English (written and spoken).
Jul 26, 2025
Full time
Are you an experienced regulatory affairs professional looking for a new opportunity? We are currently seeking a talented Regulatory Affairs Consultant to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European locations. As the Regulatory Affairs Consultant you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological products. Primary Tasks & Responsibilities: Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports. Assess change controls and provide regulatory assessments of quality changes in production and quality control. Review study reports from the quality control and production departments to ensure compliance with regulatory requirements. Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies. Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities. Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions. Identify, escalate, and mitigate risks associated with regulatory procedures and activities. Experience and Knowledge Requirements: University-level education, preferably in Life Sciences, or equivalent by experience. Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry. Strong understanding of CMC and post-approval regulatory requirements. Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations. Knowledge of biological processes. Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification/validation principles. Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued. Team spirit, flexibility, accountability, and organizational skills. Fluent in English (written and spoken).
Summary of This Role:- This Senior Consultant; leads and oversees complex evidence evaluation and network meta-analysis (NMA) projects, ensuring the use of robust methodologies and high-quality outputs. provides statistical capabilities and methodological leadership throughout all project stages, from planning to completion. leverages his/her expertise in evidence synthesis, systematic review methodologies, and advanced statistical techniques to design, develop, and deliver client solutions. applies proficiency in statistical theory, data analysis and interpretation, regression analysis, and various statistical software tools (such as WinBugs, R, Stata, Python, and SAS) to drive project success. This role requires a Master's or Doctoral Degree in Health Economics, Health Policy, Statistics, Biostatistics, Mathematics, or other related quantitative fields. Knowledge and Experience: Training and extensive experience in health economics, including the conceptualization and development of systematic literature reviews and network meta-analyses (8+ years, ideally in a consultancy environment) Strong basis in fundamental statistical concepts and methods and familiarity with techniques such as the development of predictive equations, survival analysis (including parametric methods), longitudinal data analysis, meta-analysis, mixed treatment comparison, and other hierarchical analysis techniques Familiarity with machine learning techniques and Bayesian statistics is a plus Strong communication (spoken and written) and problem-solving skills, and an ability to learn quickly Ability to communicate effectively, in non-technical terms, with project team members and clients Experience in managing projects and leading/coaching a project team Keen interest in medical research, provision of healthcare, and the pharmaceutical industry Skills: Strong computing skills (MS Office), including MS Excel High analytical ability Excellent scientific, business writing, and presentation skills with close attention to detail Ability to work under pressure to meet multiple and sometimes competing deadlines Exceptional communication skills, both oral and in writing, especially in the relaying of technical information and what is essential and strategic to the client Self-motivation, enthusiasm, ambition, and flexibility Competent in written and spoken English Software: SAS (Base, Stat, Graph, Macro), R, SPSS, STATA, and WinBUGS; Python is a plus Education Master's degree or equivalent in either life science or a quantitative discipline, such as health economics, economics, mathematics, or statistics
Jul 25, 2025
Full time
Summary of This Role:- This Senior Consultant; leads and oversees complex evidence evaluation and network meta-analysis (NMA) projects, ensuring the use of robust methodologies and high-quality outputs. provides statistical capabilities and methodological leadership throughout all project stages, from planning to completion. leverages his/her expertise in evidence synthesis, systematic review methodologies, and advanced statistical techniques to design, develop, and deliver client solutions. applies proficiency in statistical theory, data analysis and interpretation, regression analysis, and various statistical software tools (such as WinBugs, R, Stata, Python, and SAS) to drive project success. This role requires a Master's or Doctoral Degree in Health Economics, Health Policy, Statistics, Biostatistics, Mathematics, or other related quantitative fields. Knowledge and Experience: Training and extensive experience in health economics, including the conceptualization and development of systematic literature reviews and network meta-analyses (8+ years, ideally in a consultancy environment) Strong basis in fundamental statistical concepts and methods and familiarity with techniques such as the development of predictive equations, survival analysis (including parametric methods), longitudinal data analysis, meta-analysis, mixed treatment comparison, and other hierarchical analysis techniques Familiarity with machine learning techniques and Bayesian statistics is a plus Strong communication (spoken and written) and problem-solving skills, and an ability to learn quickly Ability to communicate effectively, in non-technical terms, with project team members and clients Experience in managing projects and leading/coaching a project team Keen interest in medical research, provision of healthcare, and the pharmaceutical industry Skills: Strong computing skills (MS Office), including MS Excel High analytical ability Excellent scientific, business writing, and presentation skills with close attention to detail Ability to work under pressure to meet multiple and sometimes competing deadlines Exceptional communication skills, both oral and in writing, especially in the relaying of technical information and what is essential and strategic to the client Self-motivation, enthusiasm, ambition, and flexibility Competent in written and spoken English Software: SAS (Base, Stat, Graph, Macro), R, SPSS, STATA, and WinBUGS; Python is a plus Education Master's degree or equivalent in either life science or a quantitative discipline, such as health economics, economics, mathematics, or statistics
We are seeking a dynamic and experienced Regulatory Affairs Project Manager to join our team. This role offers the flexibility of being home or office-based in various European countries. About the Role: As a Regulatory Affairs Project Manager, you will be at the forefront of leading internal projects for Parexel clients. You will provide a broad range of consulting services, working within project guidelines to identify, refine, and address client issues while achieving project objectives. Key Responsibilities: Own client relationships and ensure high client satisfaction through effective communication Lead project initiation, execution, control, and closure processes Manage projects to completion within budget, schedule, and contract specifications Oversee resource planning, team management, and budget control Ensure compliance with quality standards, SOPs, and local regulations Provide guidance to project team members on technical and process issues Qualifications: University Degree in a Scientific or Technical Discipline (Advanced Degree preferred) Extensive experience in Regulatory Affairs within an industry-related environment Good understanding and hands on experience of marketing authorisation application (MAA) process Strong project management skills (PMP or equivalent certification is a plus) CRO experience Excellent financial management skills Outstanding interpersonal and intercultural communication skills, both written and verbal Fluency in English
Jul 25, 2025
Full time
We are seeking a dynamic and experienced Regulatory Affairs Project Manager to join our team. This role offers the flexibility of being home or office-based in various European countries. About the Role: As a Regulatory Affairs Project Manager, you will be at the forefront of leading internal projects for Parexel clients. You will provide a broad range of consulting services, working within project guidelines to identify, refine, and address client issues while achieving project objectives. Key Responsibilities: Own client relationships and ensure high client satisfaction through effective communication Lead project initiation, execution, control, and closure processes Manage projects to completion within budget, schedule, and contract specifications Oversee resource planning, team management, and budget control Ensure compliance with quality standards, SOPs, and local regulations Provide guidance to project team members on technical and process issues Qualifications: University Degree in a Scientific or Technical Discipline (Advanced Degree preferred) Extensive experience in Regulatory Affairs within an industry-related environment Good understanding and hands on experience of marketing authorisation application (MAA) process Strong project management skills (PMP or equivalent certification is a plus) CRO experience Excellent financial management skills Outstanding interpersonal and intercultural communication skills, both written and verbal Fluency in English
We are seeking a dynamic and experienced Regulatory Affairs Project Manager to join our team. This role offers the flexibility of being home or office-based in various European countries. About the Role: As a Regulatory Affairs Project Manager, you will be at the forefront of leading internal projects for Parexel clients. You will provide a broad range of consulting services, working within project guidelines to identify, refine, and address client issues while achieving project objectives. Key Responsibilities: Own client relationships and ensure high client satisfaction through effective communication Lead project initiation, execution, control, and closure processes Manage projects to completion within budget, schedule, and contract specifications Oversee resource planning, team management, and budget control Ensure compliance with quality standards, SOPs, and local regulations Provide guidance to project team members on technical and process issues Qualifications: University Degree in a Scientific or Technical Discipline (Advanced Degree preferred) Extensive experience in Regulatory Affairs within an industry-related environment Strong project management skills (PMP or equivalent certification is a plus) CRO experience Excellent financial management skills Outstanding interpersonal and intercultural communication skills, both written and verbal Fluency in English
Jul 24, 2025
Full time
We are seeking a dynamic and experienced Regulatory Affairs Project Manager to join our team. This role offers the flexibility of being home or office-based in various European countries. About the Role: As a Regulatory Affairs Project Manager, you will be at the forefront of leading internal projects for Parexel clients. You will provide a broad range of consulting services, working within project guidelines to identify, refine, and address client issues while achieving project objectives. Key Responsibilities: Own client relationships and ensure high client satisfaction through effective communication Lead project initiation, execution, control, and closure processes Manage projects to completion within budget, schedule, and contract specifications Oversee resource planning, team management, and budget control Ensure compliance with quality standards, SOPs, and local regulations Provide guidance to project team members on technical and process issues Qualifications: University Degree in a Scientific or Technical Discipline (Advanced Degree preferred) Extensive experience in Regulatory Affairs within an industry-related environment Strong project management skills (PMP or equivalent certification is a plus) CRO experience Excellent financial management skills Outstanding interpersonal and intercultural communication skills, both written and verbal Fluency in English
Overall Summary about this role: The Principal Consultant, Advanced Analytics: Data Science contributes statistical capabilities and methodological leadership at all stages of projects, from planning to completion. The role would work with junior team members in designing, developing, and delivering client solutions across multiple projects - leveraging competencies in statistical theory, data analysis and interpretation, regression analysis, machine learning algorithm development, deep learning, and natural language processing techniques. The individual must have a Master's or Doctoral Degree in Health Economics, Health Policy, Statistics, Biostatistics, Mathematics, or other quantitative fields. They should be proficient in data analytics and statistical software/tools like R, Stata, Python, and SAS. Essential Knowledge, Experience, Skills and Education you will need to have to qualify for this role: Knowledge and Experience; Strong basis in fundamental statistical concepts and methods and familiarity with techniques such as development of predictive equations, survival analysis (including parametric methods), longitudinal data analysis, meta-analysis, mixed treatment comparison, and other hierarchical analysis techniques. Familiarity with machine learning techniques and Bayesian statistics is a plus. Strong statistical programming skills with standard software, including SAS, R, or STATA. Strong communication (spoken and written) and problem-solving skills, and an ability to learn quickly. Ability to communicate effectively, in non-technical terms, with project team members. Ability to work well in a team as well as independently and be able to take leadership role with regard to methodological elements in projects. Skills: Six or more years of working experience with healthcare consulting or pharmaceutical organizations. Familiarity with machine learning use cases in HEOR including the prediction of risk of various health care events; the causal estimation of treatment effects; developing models for economic evaluation; and model/data transparency. Willingness to work under pressure to meet multiple and sometimes competing deadlines. Excellent scientific, business writing, and presentation skills with close attention to detail. Exceptional communication skills, especially in the relaying of technical information and project concepts. Competent in written and spoken English. Proficient in SAS (Base, Stat, Graph, Macro), R, SPSS, STATA, and Python. Education: MSc or PhD in Data Science, Medical Statistics, Computational Biology, Health Economics, Health Policy, Statistics, Biostatics, Mathematics or other quantitative fields. Key Accountabilities: Project Execution To direct project teams in the design, development and delivery of client solutions across multiple projects. To provide high level input to the development of client deliverables including the provision of support to the delivery team in the development of strategic recommendations tailored to individual projects. To provide advice and support to existing clients both within and outside of projects. To help manage existing business accounts and identify new business opportunities for Parexel with existing and new clients. To proactively mentor and develop members of the team to help achieve best in class status. To ensure the optimal levels of client management are maintained at all levels and that the training and support to achieve best practice consultancy standards are achieved. To ensure quality standards are adhered to on all projects and new methodologies and techniques are adequately assessed and implemented. To foster thought leadership opportunities in Advanced Analytics. To work with Senior Management colleagues to identify further service opportunities. Additional Responsibilities The Principal Consultant, Advanced Analytics is responsible for ensuring that all assigned projects are being conducted in an efficient manner and that quality and client satisfaction is maximized at all times ensuring the direction of the project and the quality of the deliverables meet the project objectives and the client needs. Further, Principal Consultants are expected to support and train the Senior associates and Associates in their daily duties and to flag any areas of acute training needs to their line managers. Supported by the senior staff and Business Development partners, the Principal Consultant is responsible for maintaining client relationships on their projects. In addition, the individual will be expected to contribute to the continuing growth and improvement of the business unit through taking ownership of company and business unit processes and initiatives as well as contributing to the Senior Management Team's focus and direction. The Principal Consultant will also be expected to meet stated targets for new business development. Candidates will be part of multi-disciplinary research teams and will be expected to provide statistical expertise and methodological leadership at all stages of projects from planning to completion. Duties will vary according to the nature of the projects. These may include independently contributing to the preparation of study protocols, data manipulation and analysis, development of machine learning algorithms, application of deep learning and natural language processing techniques, and assisting with the interpretation and dissemination of findings. Candidates are expected to also lead and support ongoing innovation objectives of the unit in the field of health outcomes analysis which warrants having thought leadership skills. Candidates are expected to also support ongoing thought leadership and innovation objectives of the unit in the field of advanced analytics including, but not limited to: Supervised and unsupervised learning Variations in machine learning algorithm development such as regression, classification, clustering, and dimensionality reduction Variations of ensemble methods such as boosting, bagging, and stacking to improve model performance Deep learning Super learners Targeted learning Target maximum likelihood estimation Target trial emulation and other causal inference applications Causal modelling Predictive modelling Feature engineering Natural language processing Large language models NB Candidates to please note that VISA sponsorship is not supported for this role.
Feb 14, 2025
Full time
Overall Summary about this role: The Principal Consultant, Advanced Analytics: Data Science contributes statistical capabilities and methodological leadership at all stages of projects, from planning to completion. The role would work with junior team members in designing, developing, and delivering client solutions across multiple projects - leveraging competencies in statistical theory, data analysis and interpretation, regression analysis, machine learning algorithm development, deep learning, and natural language processing techniques. The individual must have a Master's or Doctoral Degree in Health Economics, Health Policy, Statistics, Biostatistics, Mathematics, or other quantitative fields. They should be proficient in data analytics and statistical software/tools like R, Stata, Python, and SAS. Essential Knowledge, Experience, Skills and Education you will need to have to qualify for this role: Knowledge and Experience; Strong basis in fundamental statistical concepts and methods and familiarity with techniques such as development of predictive equations, survival analysis (including parametric methods), longitudinal data analysis, meta-analysis, mixed treatment comparison, and other hierarchical analysis techniques. Familiarity with machine learning techniques and Bayesian statistics is a plus. Strong statistical programming skills with standard software, including SAS, R, or STATA. Strong communication (spoken and written) and problem-solving skills, and an ability to learn quickly. Ability to communicate effectively, in non-technical terms, with project team members. Ability to work well in a team as well as independently and be able to take leadership role with regard to methodological elements in projects. Skills: Six or more years of working experience with healthcare consulting or pharmaceutical organizations. Familiarity with machine learning use cases in HEOR including the prediction of risk of various health care events; the causal estimation of treatment effects; developing models for economic evaluation; and model/data transparency. Willingness to work under pressure to meet multiple and sometimes competing deadlines. Excellent scientific, business writing, and presentation skills with close attention to detail. Exceptional communication skills, especially in the relaying of technical information and project concepts. Competent in written and spoken English. Proficient in SAS (Base, Stat, Graph, Macro), R, SPSS, STATA, and Python. Education: MSc or PhD in Data Science, Medical Statistics, Computational Biology, Health Economics, Health Policy, Statistics, Biostatics, Mathematics or other quantitative fields. Key Accountabilities: Project Execution To direct project teams in the design, development and delivery of client solutions across multiple projects. To provide high level input to the development of client deliverables including the provision of support to the delivery team in the development of strategic recommendations tailored to individual projects. To provide advice and support to existing clients both within and outside of projects. To help manage existing business accounts and identify new business opportunities for Parexel with existing and new clients. To proactively mentor and develop members of the team to help achieve best in class status. To ensure the optimal levels of client management are maintained at all levels and that the training and support to achieve best practice consultancy standards are achieved. To ensure quality standards are adhered to on all projects and new methodologies and techniques are adequately assessed and implemented. To foster thought leadership opportunities in Advanced Analytics. To work with Senior Management colleagues to identify further service opportunities. Additional Responsibilities The Principal Consultant, Advanced Analytics is responsible for ensuring that all assigned projects are being conducted in an efficient manner and that quality and client satisfaction is maximized at all times ensuring the direction of the project and the quality of the deliverables meet the project objectives and the client needs. Further, Principal Consultants are expected to support and train the Senior associates and Associates in their daily duties and to flag any areas of acute training needs to their line managers. Supported by the senior staff and Business Development partners, the Principal Consultant is responsible for maintaining client relationships on their projects. In addition, the individual will be expected to contribute to the continuing growth and improvement of the business unit through taking ownership of company and business unit processes and initiatives as well as contributing to the Senior Management Team's focus and direction. The Principal Consultant will also be expected to meet stated targets for new business development. Candidates will be part of multi-disciplinary research teams and will be expected to provide statistical expertise and methodological leadership at all stages of projects from planning to completion. Duties will vary according to the nature of the projects. These may include independently contributing to the preparation of study protocols, data manipulation and analysis, development of machine learning algorithms, application of deep learning and natural language processing techniques, and assisting with the interpretation and dissemination of findings. Candidates are expected to also lead and support ongoing innovation objectives of the unit in the field of health outcomes analysis which warrants having thought leadership skills. Candidates are expected to also support ongoing thought leadership and innovation objectives of the unit in the field of advanced analytics including, but not limited to: Supervised and unsupervised learning Variations in machine learning algorithm development such as regression, classification, clustering, and dimensionality reduction Variations of ensemble methods such as boosting, bagging, and stacking to improve model performance Deep learning Super learners Targeted learning Target maximum likelihood estimation Target trial emulation and other causal inference applications Causal modelling Predictive modelling Feature engineering Natural language processing Large language models NB Candidates to please note that VISA sponsorship is not supported for this role.