Current jobs related to Regulatory Affairs Director - Stevenage, Hertfordshire - GSK
-
Director of Regulatory Affairs
2 weeks 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...
-
Regulatory Affairs Director, Gene Therapy
2 weeks 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.
-
Senior Manager, CMC Regulatory Affairs
1 week 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...
-
Director of Global Regulatory Compliance
1 week 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...
-
Senior Director, Biologics Regulatory CMC
1 week 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,...
-
Senior Director Regulatory CMC Lead
2 weeks 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...
-
Executive Director, Translational Sciences
2 weeks ago
Stevenage, Hertfordshire, United Kingdom GlaxoSmithKline Full timeJob SummaryThe Executive Director, Translational Sciences will lead innovative disease area translational initiatives to inform therapy area and programme biomarker strategies at GlaxoSmithKline.Key ResponsibilitiesProvide strategic leadership contributing to deep understanding of Disease areas enabling the development and execution of translational research...
-
Global Regulatory Compliance Officer
1 week 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...
-
Legal Director
2 weeks ago
Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full timeJob Overview:Spur Therapeutics is seeking an experienced Assistant General Counsel to join its team. The successful candidate will provide strategic legal support for the company's medical, regulatory, and research activities. This is a hybrid role based in Stevenage, UK.Key Accountabilities:Reviewing, negotiating, and drafting various agreements related to...
-
CMC Regulatory Strategy Manager
2 weeks 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...
-
Global Regulatory Expert
1 week 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.
-
Director of Innovation and Discovery
2 days ago
Stevenage, Hertfordshire, United Kingdom GlaxoSmithKline Full timeAbout the Job:We are looking for a Director of Innovation and Discovery to join our Translational Unit. As a key member of the RITU leadership team, you will be responsible for leading innovative disease area translational initiatives to inform therapy area and programme biomarker strategies. You will work closely with the RITU leadership team, research unit...
-
Regulatory Strategy Lead
1 week 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...
-
Global CMC Regulatory Expert
1 week 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...
-
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...
-
CMC Director
1 week ago
Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full timeJob Title: Senior Director, Biologics Regulatory CMCThe 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...
-
Regulatory Affairs Manager
2 weeks ago
Stevenage, Hertfordshire, United Kingdom Carbon60 Full timeAbout the RoleAs a Compliance Manager at Carbon60, you will be responsible for ensuring that all facilities management operations are conducted in accordance with relevant laws, regulations, and industry standards. You will work closely with senior management to develop and implement effective compliance strategies, providing guidance and support to...
-
Regulatory Director, Gene Therapy Programs
1 week 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...
-
Pharmacovigilance and Regulatory Lead
6 days ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeAbout the Role:We are looking for an experienced Director of Pharmacovigilance and Lifecycle Management to lead our quality business partner team. As a key member of the Function & Process Quality Leadership team, you will develop and implement quality strategies to ensure compliance and patient safety.Key Responsibilities:Provide leadership and guidance to...
-
Stevenage, Hertfordshire, United Kingdom ENGINEERINGUK Full timeWe are seeking a Director of Quality Excellence: Biopharma Industry to join our team at ENGINEERINGUK. This is a critical role that requires exceptional leadership skills and a deep understanding of the biopharma industry.The estimated salary for this position is between £150,000 - £220,000 per annum, depending on experience. As a Director of Quality...
Regulatory Affairs Director
1 month ago
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 are currently seeking a Regulatory Affairs Director - CMC to join our team in the UK. The successful candidate will have a strong background in regulatory affairs and experience in managing complex worldwide CMC regulatory requirements.
The key responsibilities of this role include:
- Developing and implementing CMC regulatory strategies to support product submissions and lifecycle maintenance
- Coordinating the preparation of technical (CMC) regulatory documents and ensuring compliance with regulations
- Mentoring and training staff on regulatory procedures and best practices
In return, we offer a competitive salary of $150,000 - $200,000 per annum, depending on experience, plus benefits including health insurance, retirement plan membership, and shares and savings program.
GSK is committed to creating a workplace that is inclusive and diverse. We welcome applications from individuals with disabilities and encourage women to apply.
