Regulatory Strategy Lead
4 days ago
The 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 candidate will have at least 10 years' experience in CMC regulatory disciplines, preferably in a pharmaceutical or biotech company. Strong scientific background, excellent communication and interpersonal skills, and ability to work collaboratively in matrix teams are essential.
This is a hybrid role based at the Stevenage, UK or Boston, MA office location. The successful candidate will be responsible for developing CMC regulatory strategy, submission generation, submission reviews, and health authority interactions.
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Global Regulatory Affairs Director
1 month ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeCompany OverviewGSK is a global biopharma company dedicated to unifying science, technology, and talent to get ahead of disease together. Our commitment is to positively impact the health of billions of people while delivering stronger, more sustainable shareholder returns.About the RoleWe are seeking a driven Global Regulatory Affairs Director to lead...
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Senior Director Regulatory CMC Lead
7 days 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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Strategic Oncology Regulatory Lead
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Stevenage, Hertfordshire, United Kingdom GSK Full timeJob Opportunity:GSK is seeking a highly skilled Global Regulatory Affairs Director to join our team in the UK.About GSKWe have bold ambitions for patients, aiming to positively impact health. Our R&D team is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.Job Description:Act as the...
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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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EHS Strategy Lead
1 week ago
Stevenage, Hertfordshire, United Kingdom Carbon 60 Full timeWe are seeking an EHS Strategy Lead to join our team at Carbon60. This is an exciting opportunity for a qualified professional to take on a leadership role in our EHS department and drive forward our EHS agenda.Responsibilities:Lead the development and implementation of effective EHS strategies to ensure compliance with regulatory requirements and industry...
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Pharmacovigilance and Regulatory Lead
7 hours 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...
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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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Senior Director, Biologics Regulatory CMC
4 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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CMC Regulatory Manager
4 weeks ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeOpportunity OverviewGSK is a leading global biopharma company that has a bold ambition for patients: positively impacting the health of 2.5 billion people over the next 10 years.We are currently seeking a CMC Regulatory Manager to join our team in the UK. The successful candidate will have a strong background in regulatory affairs and experience in managing...
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Senior Quality Strategy Lead
4 weeks ago
Stevenage, Hertfordshire, United Kingdom Lifelancer Full timeDirector, QMS Strategy and IntegrationWe are seeking a visionary leader to provide strategic direction for our Research Development Quality Management System (RD QMS) at GSK. This role ensures the QMS is robust, compliant, and aligned with long-term organizational goals.About the RoleOversee the operation and continuous improvement of the RD QMS, ensuring it...
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Senior Manager, CMC Regulatory Affairs
3 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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Business Strategy Consultant
1 week ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeGSK seeks a talented Business Strategy Consultant to develop and deliver quality strategies for clinical development. The ideal candidate will have a passion for developing business plans, identifying quality risks, and driving continuous improvement.About the RoleThis Clinical Development Director position is responsible for developing and delivering...
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Regulatory Compliance Director
4 weeks ago
Stevenage, Hertfordshire, United Kingdom People Group Limited Full timePeople Group Limited is currently seeking a Regulatory Compliance Director to join our team. The successful candidate will be responsible for developing and implementing effective compliance strategies to minimize risk and ensure adherence to regulatory requirements.Develop and implement effective compliance strategies to minimize risk and ensure adherence...
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Regulatory Affairs Director, Gene Therapy
5 days 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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Global Regulatory Compliance Officer
3 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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Senior Regulatory Affairs Strategist
4 weeks ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeAbout the RoleWe are seeking a highly skilled Senior Regulatory Affairs Strategist to join our team at GSK. As a key member of our Regulatory Affairs department, you will play a critical role in shaping the development and implementation of our regulatory strategy for pharmaceutical products.This is an exciting opportunity for a talented individual with a...
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CMC Director
4 days 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...
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Oncology Data Strategy Director
1 week ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeJob OverviewWe are seeking a highly skilled Data Asset Management Director to join our team at GSK Oncology.The successful candidate will have a strong background in oncology indications, with experience in partnering with disease strategy leads to drive alignment in asset development across DU's. A key aspect of this role is to support the DU head and...
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Regulatory Director, Gene Therapy Programs
3 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
4 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.