Regulatory Affairs Director
6 days ago
Job Summary
Gilead Sciences International, Ltd. is seeking an experienced Regulatory Affairs professional to join our global team as an Associate Director, Regulatory Affairs CMC. In this role, you will be responsible for defining the regulatory strategy, plans, and objectives for assigned products or projects.
Key Responsibilities
- Act as one of the EU Regulatory leads for Kite's existing commercial and/or clinical programs.
- Define the regulatory strategy, plans, and objectives for assigned products or projects.
- Contribute to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies, and capabilities.
- Take the lead on CMC submissions and collaborate with headquarters' colleagues to shape dossier content for global rollout and life cycle management in EU-aligned regions.
- Oversee the preparation and maintenance of CMC regulatory submissions for assigned products or projects, guiding and advising colleagues to ensure thorough and compliant completion of these activities.
- Play a leadership role in ad hoc or special projects aimed at continuously improving or advancing Regulatory Affairs capabilities.
Requirements
- Strong life sciences background, ideally in cell & gene therapy.
- In-depth knowledge of current global and regional trends in biologics but ideally also cell and gene therapy regulatory affairs.
- In-depth knowledge of relevant health authorities (HAs), including people, system, processes and requirements.
- Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives to support a team-oriented, highly matrixed environment.
- Demonstrated ability to learn quickly while being flexible and adaptable to change, and to move between projects easily and provide support/expertise where needed.
- Excellent knowledge of Microsoft Office tools and the Veeva platform quality/regulatory/compliance systems.
Equal Employment Opportunity (EEO)
Gilead Sciences International, Ltd. is an equal opportunity employer and welcomes applications from diverse candidates.
-
Regulatory Affairs Director
5 days ago
Cambridge, Cambridgeshire, United Kingdom Lifelancer Full timeJob DescriptionJob Title: Director, Global Regulatory Affairs, OncologyJob Summary:We are seeking an experienced and skilled Director, Global Regulatory Affairs, Oncology to join our team at Lifelancer. As a key member of our organization, you will be responsible for developing and executing regulatory strategies for our assigned programs and products.Key...
-
Regulatory Affairs Director
6 days ago
Cambridge, Cambridgeshire, United Kingdom Lifelancer Full timeJob DescriptionJob Title: Director, Global Regulatory Affairs, OncologyJob Summary:We are seeking an experienced and skilled Director, Global Regulatory Affairs, Oncology to join our team at Lifelancer. As a key member of our organization, you will be responsible for developing and executing regulatory strategies for our assigned programs and products.Key...
-
Regulatory Affairs Director
19 hours ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeJob Summary:Gilead Sciences International, Ltd. is seeking an experienced Regulatory Affairs professional to join our team as an Associate Director, Regulatory Strategy. This role will be responsible for providing strategic guidance and oversight to our in-market partners in the Gilead Patient Solutions (GPS) region, ensuring compliance with regulatory...
-
Regulatory Affairs Director
22 hours ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeJob Summary:Gilead Sciences International, Ltd. is seeking an experienced Regulatory Affairs professional to join our team as an Associate Director, Regulatory Strategy. This role will be responsible for providing strategic guidance and oversight to our in-market partners in the Gilead Patient Solutions (GPS) region, ensuring compliance with regulatory...
-
Regulatory Affairs Director
2 days ago
Cambridge, Cambridgeshire, United Kingdom Lifelancer Full timeJob DescriptionJob SummaryWe are seeking a highly experienced Regulatory Affairs Director to lead our global regulatory strategy for oncology products. As a key member of our team, you will be responsible for developing and executing regulatory strategies to ensure compliance with global regulations and to drive business growth.Key ResponsibilitiesRegulatory...
-
Regulatory Affairs Director
2 days ago
Cambridge, Cambridgeshire, United Kingdom Lifelancer Full timeJob DescriptionJob SummaryWe are seeking a highly experienced Regulatory Affairs Director to lead our global regulatory strategy for oncology products. As a key member of our team, you will be responsible for developing and executing regulatory strategies to ensure compliance with global regulations and to drive business growth.Key ResponsibilitiesRegulatory...
-
Regulatory Affairs Director
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Relay Therapeutics Full timeThe Opportunity:We are seeking a seasoned regulatory professional to join our team at Relay Therapeutics as a Director of Regulatory Affairs. As a key member of our regulatory team, you will play a critical role in defining and implementing innovative regulatory strategies to drive the development and approval of our transformative pipeline.Your Role:You...
-
Regulatory Affairs Director
1 day ago
Cambridge, Cambridgeshire, United Kingdom Relay Therapeutics Full timeThe Opportunity:We are seeking a seasoned regulatory professional to join our team at Relay Therapeutics as a Director of Regulatory Affairs. As a key member of our regulatory team, you will play a critical role in shaping and implementing our regulatory strategies to drive the development and approval of our innovative pipeline.Your Role:You will report to...
-
Regulatory Affairs Director
23 hours ago
Cambridge, Cambridgeshire, United Kingdom Relay Therapeutics Full timeThe Opportunity:We are seeking a seasoned regulatory professional to join our team at Relay Therapeutics as a Director of Regulatory Affairs. As a key member of our regulatory team, you will play a critical role in shaping and implementing our regulatory strategies to drive the development and approval of our innovative pipeline.Your Role:You will report to...
-
Senior Director of Regulatory Affairs
7 days ago
Cambridge, Cambridgeshire, United Kingdom Hyper Recruitment Solutions LTD Full timeJob Title: Director of Business OperationsCompany: Hyper Recruitment Solutions LTDLocation: RemoteJob Type: Full-timeSalary: £110,000 - £130,000/annumBenefits: Flexible benefits and on-target bonus, hybridJob Description:Overview:We are seeking a highly experienced Director of Business Operations to join our team at Hyper Recruitment Solutions LTD. As a...
-
Senior Director of Regulatory Affairs
7 days ago
Cambridge, Cambridgeshire, United Kingdom Hyper Recruitment Solutions LTD Full timeJob Title: Director of Business OperationsCompany: Hyper Recruitment Solutions LTDLocation: RemoteJob Type: Full-timeSalary: £110,000 - £130,000/annumBenefits: Flexible benefits and on-target bonus, hybridJob Description:Overview:We are seeking a highly experienced Director of Business Operations to join our team at Hyper Recruitment Solutions LTD. As a...
-
Regulatory Affairs Program Director
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom ProductLife Group Full timeRegulatory Affairs Program Director - European OperationsWe are seeking a highly experienced Regulatory Affairs Program Director to join our team at ProductLife Group. As a key member of our Regulatory Affairs department, you will be responsible for piloting and managing Regulatory Affairs outsourcing projects/programs for major clients in Europe.About...
-
Regulatory Affairs Program Director
20 hours ago
Cambridge, Cambridgeshire, United Kingdom ProductLife Group Full timeRegulatory Affairs Program Director - European OperationsProductLife Group is seeking a highly experienced Regulatory Affairs Program Director to lead our European operations. As a key member of our team, you will be responsible for managing Regulatory Affairs outsourcing projects/programs for major clients in Europe.About UsProductLife Group is a leading...
-
Regulatory Affairs Program Director
23 hours ago
Cambridge, Cambridgeshire, United Kingdom ProductLife Group Full timeRegulatory Affairs Program Director - European OperationsProductLife Group is seeking a highly experienced Regulatory Affairs Program Director to lead our European operations. As a key member of our team, you will be responsible for managing Regulatory Affairs outsourcing projects/programs for major clients in Europe.About UsProductLife Group is a leading...
-
Regulatory Affairs Director
6 days ago
Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full timeJob DescriptionOverviewBicycle Therapeutics is seeking an experienced Regulatory Affairs professional to join our team as an Associate Director, Regulatory Affairs. This role will be responsible for developing and executing regulatory strategy for assigned BicycleTx programs or projects.Key ResponsibilitiesRegulatory Strategy DevelopmentDevelop and execute...
-
Regulatory Affairs Director
4 hours ago
Cambridge, Cambridgeshire, United Kingdom TidalSense Full timeAbout the RoleTidalSense is a pioneering respiratory technology company dedicated to revolutionizing the diagnosis, monitoring, and management of chronic respiratory conditions. We are seeking a highly skilled and experienced Regulatory Affairs Director to join our team and support the compliance of our existing medical device portfolio, as well as lead our...
-
Regulatory Affairs Director
3 hours ago
Cambridge, Cambridgeshire, United Kingdom TidalSense Full timeAbout the RoleTidalSense is a pioneering respiratory technology company dedicated to revolutionizing the diagnosis, monitoring, and management of chronic respiratory conditions. We are seeking a highly skilled and experienced Regulatory Affairs Director to join our team and support the compliance of our existing medical device portfolio, as well as lead our...
-
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeAbout the RoleGilead Sciences International, Ltd. is seeking a highly skilled and experienced Director, Global Regulatory Affairs, Precision Medicine to join our team. As a key member of our regulatory affairs department, you will play a critical role in developing and executing precision medicine regulatory strategies in alignment with our global regulatory...
-
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeAbout the RoleGilead Sciences International, Ltd. is seeking a highly skilled and experienced Director, Global Regulatory Affairs, Precision Medicine to join our team. As a key member of our regulatory affairs department, you will play a critical role in developing and executing precision medicine regulatory strategies in alignment with our global regulatory...
-
Regulatory Affairs Director
4 days ago
Cambridge, Cambridgeshire, United Kingdom Reed Full timeJob SummaryWe are seeking a highly experienced Regulatory Affairs Manager to lead our quality and regulatory projects and functions. As a key member of our team, you will be responsible for maintaining and improving our robust quality management systems and ensuring adherence to regulatory requirements throughout the development lifecycle of our medical...