Current jobs related to Regulatory Affairs Director - Abingdon, Oxfordshire - Adaptimmune Therapeutics PLC
-
Regulatory Affairs Director
3 weeks ago
Abingdon, Oxfordshire, United Kingdom Adaptimmune Full timeAt Adaptimmune, we are seeking a highly skilled Regulatory Affairs Director to lead our CMC sub-team within Global Regulatory Affairs. This role provides regulatory leadership and oversight in support of our product portfolio, including CMC regulatory strategies, development plans, and risk assessments.The ideal candidate will have a strong understanding of...
-
Regulatory Affairs Director
4 weeks ago
Abingdon, Oxfordshire, United Kingdom Adaptimmune Therapeutics PLC Full timeJob Title: Senior Director of Global Regulatory Affairs CMCAdaptimmune Therapeutics PLC is a leading biotechnology company dedicated to developing innovative cell therapies for cancer treatment. We are seeking a highly experienced Senior Director of Global Regulatory Affairs CMC to lead our CMC sub-team within Global Regulatory Affairs.Key...
-
Regulatory Affairs Director
4 weeks ago
Abingdon, Oxfordshire, United Kingdom Adaptimmune Therapeutics PLC Full timeJob Title: Senior Director of Global Regulatory Affairs CMCAdaptimmune Therapeutics PLC is a leading biotechnology company dedicated to developing innovative cell therapies for cancer treatment. We are seeking a highly experienced Senior Director of Global Regulatory Affairs CMC to lead our CMC sub-team within Global Regulatory Affairs.Key...
-
Regulatory Affairs Director
4 weeks ago
Abingdon, Oxfordshire, United Kingdom Adaptimmune Therapeutics plc Full timeJob SummaryAdaptimmune Therapeutics plc is seeking a highly skilled Regulatory Affairs Director to lead the CMC sub-team within Global Regulatory Affairs. The successful candidate will provide regulatory leadership and oversight to the CMC sub-team, ensuring the development and execution of robust CMC regulatory strategies for the Adaptimmune portfolio.Key...
-
Regulatory Affairs Director
4 weeks ago
Abingdon, Oxfordshire, United Kingdom Adaptimmune Full timeJob Title: Senior Director of Global Regulatory Affairs CMCAdaptimmune is a pioneering cell therapy company with a strong presence in the UK and US. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.Our...
-
Regulatory Affairs Director
4 weeks ago
Abingdon, Oxfordshire, United Kingdom Adaptimmune Full timeJob Title: Senior Director of Global Regulatory Affairs CMCAdaptimmune is a pioneering cell therapy company with a strong presence in the UK and US. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.Our...
-
Regulatory Scientist Leader
2 months ago
Abingdon, Oxfordshire, United Kingdom Adaptimmune Full timeJob Title: Principal Regulatory ScientistAdaptimmune is a pioneering cell therapy company that has revolutionized the field of cancer treatment. As a Principal Regulatory Scientist, you will play a critical role in leading and providing late phase development expertise on cross-functional projects across the Vector Process and Analytical function.Key...
-
Regulatory Scientist Leader
2 months ago
Abingdon, Oxfordshire, United Kingdom Adaptimmune Full timeJob Title: Principal Regulatory ScientistAdaptimmune is a pioneering cell therapy company that has revolutionized the field of cancer treatment. As a Principal Regulatory Scientist, you will play a critical role in leading and providing late phase development expertise on cross-functional projects across the Vector Process and Analytical function.Key...
-
Associate Director, Client Management Lead
4 weeks ago
Abingdon, Oxfordshire, United Kingdom https:jobs-redefined.cositemap Full timeRevolutionizing Cancer Treatment with Innovative TherapiesAt Replimune, we are committed to transforming cancer care with cutting-edge therapies that activate a powerful and durable full-body anti-tumor response. As a key member of our team, you will play a critical role in driving this mission forward.Job SummaryWe are seeking an experienced Associate...
-
Senior Manager, Quality Control Stability
3 weeks ago
Abingdon, Oxfordshire, United Kingdom Replimune, Inc. Full timeAt Replimune, Inc., we are revolutionizing cancer treatment with innovative therapies designed to activate a powerful and durable full-body anti-tumor response. As the Associate Director, Quality Control Stability, you will play a critical role in setting up and maintaining a compliant stability program and regulatory submissions in a clinical and commercial...
-
Medical Director
4 weeks ago
Abingdon, Oxfordshire, United Kingdom Immunocore Full timeJob Title: Physician DirectorImmunocore is seeking a highly skilled Physician Director to lead our clinical development efforts in Infectious Diseases. As a key member of our team, you will be responsible for shaping our clinical development strategy and plans, working closely with our Development and Discovery Program Leads and counterparts in Regulatory,...
-
Medical Director
4 weeks ago
Abingdon, Oxfordshire, United Kingdom Immunocore Full timeJob Title: Physician DirectorImmunocore is seeking a highly skilled Physician Director to lead our clinical development efforts in Infectious Diseases. As a key member of our team, you will be responsible for shaping our clinical development strategy and plans, working closely with our Development and Discovery Program Leads and counterparts in Regulatory,...
-
Abingdon, Oxfordshire, United Kingdom Immunocore Full timeJob Title: Medical Director for Infectious Disease Clinical DevelopmentImmunocore is seeking a highly skilled Medical Director for Infectious Disease Clinical Development to lead our clinical development strategy and plans. As a key member of our team, you will work closely with Development and Discovery Program Leads and counterparts in Regulatory, Clinical...
-
Director of Quality Control
1 month ago
Abingdon, Oxfordshire, United Kingdom Hobson Prior Full timeAssociate Director - QC StabilityHobson Prior is partnering with a leading biotechnology company to find an exceptional Associate Director - QC Stability to join their dynamic team.This is a unique opportunity to lead and maintain a stability program, ensuring compliance and overseeing sample management. You will provide expert input into regulatory...
-
Director of Quality Control
1 month ago
Abingdon, Oxfordshire, United Kingdom Hobson Prior Full timeAssociate Director - QC StabilityHobson Prior is partnering with a leading biotechnology company to find an exceptional Associate Director - QC Stability to join their dynamic team.This is a unique opportunity to lead and maintain a stability program, ensuring compliance and overseeing sample management. You will provide expert input into regulatory...
-
Associate Director of Experience
4 weeks ago
Abingdon, Oxfordshire, United Kingdom Hobson Prior Full timeJob Title: Associate Experience DirectorWe are seeking an experienced professional to join our team as an Associate Experience Director. In this role, you will be responsible for managing and maintaining a stability program, ensuring compliance and overseeing sample management.Key Responsibilities:Manage and maintain a compliant stability program, including...
-
Associate Director of Experience
1 month ago
Abingdon, Oxfordshire, United Kingdom Hobson Prior Full timeJob DescriptionAs an Associate Experience Director at Hobson Prior, you will play a critical role in managing and maintaining a stability program that ensures compliance and oversees sample management. Your expertise will be invaluable in providing input into regulatory submissions and supporting troubleshooting assays to drive continuous improvement.Key...
-
Associate Director of Experience
1 month ago
Abingdon, Oxfordshire, United Kingdom Hobson Prior Full timeJob DescriptionAs an Associate Experience Director at Hobson Prior, you will play a critical role in managing and maintaining a stability program that ensures compliance and oversees sample management. Your expertise will be invaluable in providing input into regulatory submissions and supporting troubleshooting assays to drive continuous improvement.Key...
-
Associate Director
4 weeks ago
Abingdon, Oxfordshire, United Kingdom Hobson Prior Full timeAssociate Director - QC StabilityHobson Prior is partnering with a biotechnology company to find an experienced Associate Director - QC Stability to join their dynamic team. In this role, you will be responsible for managing and maintaining a stability program, ensuring compliance and overseeing sample management. You will also provide expert input into...
-
Clinical Operations Director
4 weeks ago
Abingdon, Oxfordshire, United Kingdom https:www.energyjobline.comsitemap Full timeJob SummaryWe are seeking a highly experienced Clinical Operations Director to lead our global clinical trial delivery team. The successful candidate will provide scientific and operational input and oversight, as well as leadership and management of cross-functional execution of clinical trials within our programs.The ideal candidate will have extensive...
Regulatory Affairs Director
2 months ago
Adaptimmune Therapeutics PLC is a leading biotechnology company dedicated to developing innovative cell therapies for cancer treatment. We are seeking a highly experienced Senior Director of Global Regulatory Affairs CMC to lead our CMC sub-team within Global Regulatory Affairs.
Key Responsibilities:- Provide regulatory leadership and oversight to the CMC sub-team, ensuring the development and execution of robust CMC regulatory strategies for our product portfolio.
- Supervise the work of Reg CMC subteam members and manage external vendors supporting the Reg CMC activities.
- Oversee CMC regulatory staff and participate in skill-development, coaching, and performance feedback of CMC regulatory staff.
- Provide guidance on scientific/technical requirements for CMC and CGMP related submissions.
- Review and/or approve CMC and CGMP related submission documents to ensure compliance with regulatory standards and scientific/technical requirements.
- Perform risk assessments for determination of probability of success for strategic regulatory CMC decisions.
- Develop and maintain collaborative relationships with internal and external stakeholders.
- Represent the company at regulatory and scientific conferences.
- Participate in due diligence activities on potential licensing, acquisition, or collaboration opportunities.
- Bachelor's Degree in a scientific discipline is required.
- Minimum of 10-15 years of relevant pharmaceutical/biotech experience, including 5 years of Global Regulatory Affairs CMC experience in the cell and gene therapy space.
- Experience with pharmaceutical development of drug substance and drug products, including analytical characterization and manufacturing process development.
- Proven understanding and ability to provide regulatory strategic guidance to drug development, registration, and post-market support teams.
- Successful track record of providing robust regulatory advice and making reasoned decisions on regulatory issues.
- Experience with filing and maintenance of regulatory dossiers (CTAs, INDs, IMPDs, BLAs/MAAs).
- Ability to effectively liaise with Regulatory Agencies and having served as lead in successful Agency interactions related to CMC submissions and product development meetings.
- Knowledge of relevant domestic and global regulations and guidance.
- Ability to work effectively in cross-functional and matrixed teams.
- Proven leadership and management experience of regulatory staff.
Adaptimmune Therapeutics PLC is an equal opportunities employer and welcomes applications from all qualified candidates. We are committed to creating an inclusive and diverse work environment.
