CMC Director
6 days ago
The estimated salary for this role is $180,000 - $220,000 per annum, depending on experience and location. We are looking for a highly experienced Senior Director to oversee the development and implementation of global regulatory CMC strategies for our assigned gene therapy programs.
- This is a hybrid role based at our Stevenage, UK or Boston, MA office location.
- Responsibilities include CMC regulatory strategy, submission generation, review and health authority interactions.
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Regulatory Affairs Director
1 month ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeJob DescriptionGSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty and general medicines.We are currently seeking a Regulatory Affairs Director - CMC to join our team in the UK. The successful candidate will have a strong...
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Senior Director, Biologics Regulatory CMC
6 days ago
Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full timeAbout the RoleWe are seeking an exceptional candidate to lead our CMC regulatory team and develop global regulatory strategies for our gene therapy programs. As Senior Director, Biologics Regulatory CMC, you will be responsible for ensuring timely and coordinated preparedness for regulatory submissions.You will work closely with cross-functional teams,...
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Senior Director Regulatory CMC Lead
1 week ago
Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full timeSpur Therapeutics: A Pioneer in Gene TherapyWe're at an inflection point in gene therapy, with emerging modalities pushing the boundaries of what's possible. As a Senior Director Regulatory CMC Lead at Spur Therapeutics, you'll play a crucial role in developing transformative adeno-associated virus (AAV) vector-mediated gene therapies.About the RoleThis...
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CMC Regulatory Strategy Manager
1 week ago
Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full timeWe are seeking an experienced professional to join our team as a Senior Director Regulatory CMC Lead. This is a unique opportunity to be part of a pioneering company in the field of gene therapy. The successful candidate will have a strong scientific background and at least 10 years of experience in CMC regulatory disciplines in a pharmaceutical or biotech...
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Senior Manager, CMC Regulatory Affairs
5 days ago
Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full timeJob DescriptionWe are looking for a highly skilled Sr. Director, Global Regulatory CMC to lead our regulatory CMC strategy development and implementation for our gene therapy programs. The ideal candidate will have at least 10 years of experience in CMC regulatory disciplines in a pharmaceutical/biotech company.The role will involve:Developing CMC regulatory...
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Sr. Director, Global Regulatory CMC
2 months ago
Stevenage, UK, Hertfordshire, United Kingdom Spur Therapeutics Full timeWhy Spur?Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's dedicated team of...
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Global CMC Regulatory Expert
6 days ago
Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full timeAbout the OpportunityWe offer a competitive salary of $175,000 per annum, plus benefits. The Sr. Director Regulatory CMC will have the opportunity to work on cutting-edge gene therapies, contribute to the development of innovative treatments, and collaborate with a talented team of professionals.This is an exciting opportunity to join a rapidly growing...
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Regulatory Affairs Director, Gene Therapy
1 week ago
Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full timeJob DescriptionSr. Director Regulatory CMC Job Summary:The Sr. Director Regulatory CMC will lead the development and implementation of global regulatory CMC strategies for assigned Spur global gene therapy programs. This role will provide strategic and operational leadership for regulatory CMC activities, interfacing with CMC, Clinical, and Clin Reg teams.
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Director of Global Regulatory Compliance
6 days ago
Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full timeAbout the RoleAt Spur Therapeutics, we are dedicated to revolutionizing gene therapy for patients worldwide. We are seeking an experienced Sr. Director, Global Regulatory CMC to join our team and contribute to our mission.The successful candidate will be responsible for developing and implementing global regulatory CMC strategies for assigned Spur gene...
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Director of Regulatory Affairs
1 week ago
Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full timeGene therapy is at a pivotal point. Amidst the plethora of emerging modalities, we've been refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives.About UsWe are a clinical-stage biotech company dedicated to developing...
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Global Regulatory Compliance Officer
6 days ago
Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full timeSr. Director Regulatory CMC Job DescriptionThis Sr. Director Regulatory CMC position is a key role within our organization, responsible for overseeing global regulatory CMC strategies for assigned Spur gene therapy programs. If you have a strong scientific background and at least 10 years of experience in CMC regulatory disciplines, we encourage you to apply...
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Regulatory Strategy Lead
6 days ago
Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full timeAbout This RoleThe Sr. Director Regulatory CMC will play a critical role in overseeing the development and implementation of global regulatory CMC strategies for assigned Spur global gene therapy programs. This position requires strategic and operational leadership for regulatory CMC activities, interfacing with CMC, Clinical, and Clin Reg teams.The ideal...
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Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full timeSpur Therapeutics: A Pioneer in Gene TherapyWe are a clinical-stage biotech company dedicated to developing innovative, one-time treatments for debilitating chronic diseases. Our integrated gene therapy platform includes research, protein engineering, and clinical development capabilities, allowing us to optimize every component of our product candidates and...
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Regulatory Director, Gene Therapy Programs
6 days ago
Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full timeKey ResponsibilitiesThe successful candidate will be responsible for:Developing CMC regulatory strategies for Spur development-phase projectsCollaborating with cross-functional colleagues to ensure consistency of approach to CMC regulatory challenges across the portfolio/platformMaintaining an awareness of CMC regulatory guidance and intelligence and...
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Global Regulatory Expert
6 days ago
Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full timeAbout the RoleSpur Therapeutics is a clinical-stage biotech company developing innovative gene therapies for patients worldwide.We are seeking a highly experienced Senior Director, CMC to oversee the development and implementation of global regulatory strategies for our assigned Spur global gene therapy programs.
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R&D Clinical Supply Chain Leadership Role
4 weeks ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeAbout the Company">GSK is a global biopharma company with a long history of innovation and commitment to improving human health. We are dedicated to creating a more sustainable future for ourselves and for generations to come.">Job Summary">We are seeking an Executive Director Clinical Interface to lead the R&D Clinical Supply Management for Medicines and...
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Senior Director Regulatory CMC
6 days ago
Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full timeAbout Spur TherapeuticsSpur Therapeutics is a clinical-stage biotech company dedicated to developing transformative adeno-associated virus (AAV) vector-mediated gene therapies. With a strong focus on innovation, we aim to create one-time treatments that set new standards of care.Our integrated gene therapy platform includes in-house capabilities in research,...
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Senior Clinical Supply Chain Director
4 weeks ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeJob Overview">GSK is a global biopharma company committed to unifying science, technology, and talent to get ahead of disease together. As an Executive Director Clinical Interface, you will play a pivotal role in driving scientific innovation across GSK's vaccine and medicine portfolio.">About the Role">The primary purpose of this role is to lead the R&D...
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Stevenage, Hertfordshire, United Kingdom GSK Full timeAbout GSK">GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas...
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Director, Global Regulatory CMC
3 weeks ago
Stevenage, United Kingdom Spur Therapeutics Full timeWhy Spur? Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's dedicated team of scientists,...
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Sr. Director, Global Regulatory Cmc
4 weeks ago
Stevenage, United Kingdom Spur Therapeutics Full timeWhy Spur?Gene therapy is at an inflection point.Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives.Come join Spur's dedicated team of scientists,...
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Sr. Director, Global Regulatory CMC
2 months ago
Stevenage, United Kingdom Spur Therapeutics Full timeWhy Spur?Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's dedicated team of scientists,...
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Sr. Director, Global Regulatory CMC
2 months ago
Stevenage, United Kingdom Spur Therapeutics Full timeWhy Spur?Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's dedicated team of scientists,...
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Sr. Director, Global Regulatory CMC
2 months ago
Stevenage, United Kingdom Spur Therapeutics Full timeWhy Spur?Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's dedicated team of scientists,...
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Sr. Director, Global Regulatory CMC
1 month ago
Stevenage, United Kingdom Spur Therapeutics Full timeJob Description Why Spur? Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's...
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Director, Global Regulatory CMC
3 weeks ago
Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full timeWhy Spur? Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's dedicated team of...
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Director, Global Regulatory CMC
3 weeks ago
Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full timeWhy Spur? Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's dedicated team of...
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Director Regulatory Science
3 weeks ago
Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full timeGene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's dedicated team of scientists, physicians...
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Director Regulatory Science
3 weeks ago
Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full timeGene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's dedicated team of scientists, physicians...
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Associate Director, Vector Ms&t
6 months ago
Stevenage, United Kingdom Adaptimmune Full time**Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.** **Our...