Regulatory Affairs Director for Global Distributor Management
3 weeks ago
Job Summary
This is an exciting opportunity for an Associate Director to join the Gilead Global Regulatory Affiliates & Distributor team. The role requires effective stakeholder management and collaboration with cross-functional teams to oversee regulatory activities across the region.
Key Responsibilities
- Management of regulatory capability for Gilead's in-market partners
- Due diligence and distributor on-/off-boarding
- Periodic regulatory training of in-market partners
- Maintenance of legal agreements with in-market partners
- Development of regional and national regulatory strategies
- Partnership with the business to understand and support commercial and access needs
- Proactive identification and resolution of emerging regulatory issues
- Regulatory input to support product launch activities
- Assessment and interpretation of regulatory intelligence
Requirements
- Experience in regulatory affairs across international markets
- Knowledge of regulatory requirements, including ICH requirements and regional requirements
- Ability to lead cross-functional teams and develop regulatory strategy
- Excellent verbal and written English communication skills
- Excellent planning and organisational skills
About Gilead Sciences International, Ltd.
Gilead Sciences International, Ltd. is a leading biopharmaceutical company dedicated to delivering innovative therapies to patients worldwide. We are committed to advancing the science of medicine and improving the lives of people affected by serious diseases.
-
Global Regulatory Affairs Director
5 days ago
Uxbridge, United Kingdom Gilead Sciences International, Ltd. Full timeGilead Sciences International, Ltd. is seeking a highly skilled Global Regulatory Affairs Director - Distributor Management to join our team. The successful candidate will be responsible for providing oversight and management of regulatory activities provided by Gilead's in-market partners in the Gilead Patient Solutions (GPS) region. This role requires...
-
Global Regulatory Affairs Manager
2 months ago
Uxbridge, United Kingdom Hays Full timeGlobal Regulatory Affairs Manager - contract jobYour new company This well-known biotech is looking for an experienced Regulatory Affairs Manager to join their established Global Regulatory Affairs team. This is a 12-month contract job with scope for extension.Your new role As Global Regulatory Affairs Manager you will support the creation of strategy and...
-
Regulatory Affairs Director
3 weeks ago
Uxbridge, United Kingdom Gilead Sciences, Inc. Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Director to lead our Global Therapeutic Area (TA) Regulatory Affairs team in Virology. As a key member of our team, you will be responsible for defining the regulatory strategy, plans, and objectives for assigned products or projects. You will also oversee the preparation and maintenance of...
-
Regulatory Affairs Director
4 weeks ago
Uxbridge, United Kingdom Lifelancer Full timeSenior Regulatory Affairs ManagerWe are seeking a highly experienced Senior Regulatory Affairs Manager to join our team at Lifelancer. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the pharmaceutical industry.Key Responsibilities:Develop and implement regulatory...
-
Regulatory Affairs Director
4 weeks ago
Uxbridge, United Kingdom Lifelancer Full timeSenior Regulatory Affairs ManagerWe are seeking a highly experienced Senior Regulatory Affairs Manager to join our team at Lifelancer. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the pharmaceutical industry.Key Responsibilities:Develop and implement regulatory...
-
Regulatory Affairs Director
1 month ago
Uxbridge, United Kingdom Parexel Full timeUnlock Your Potential in Regulatory AffairsWe are seeking a highly experienced Senior Regulatory Affairs Manager to join our team at Parexel. As a key member of our regulatory affairs team, you will play a critical role in ensuring compliance with regulatory requirements and guidelines.Key Responsibilities:Develop and implement regulatory strategies for CMC...
-
Regulatory Affairs Director
1 month ago
Uxbridge, United Kingdom Parexel Full timeUnlock Your Potential in Regulatory AffairsWe are seeking a highly experienced Senior Regulatory Affairs Manager to join our team at Parexel. As a key member of our regulatory affairs team, you will play a critical role in ensuring compliance with regulatory requirements and guidelines.Key Responsibilities:Develop and implement regulatory strategies for CMC...
-
Regulatory Affairs Strategist
1 week ago
Uxbridge, United Kingdom Proclinical Staffing Full timeProclinical Staffing is seeking a skilled Regulatory Intelligence Manager to collaborate with the Director of Regulatory Intelligence at a biotech company. This is a contract position with a focus on global monitoring and surveillance activities throughout the drug development lifecycle.The ideal candidate will be responsible for implementing and managing...
-
Regulatory Affairs Manager
4 weeks ago
Uxbridge, United Kingdom Park Street People Full timeRegulatory Affairs Manager OpportunityPark Street People Ltd is seeking a highly skilled Regulatory Affairs Manager to join their team on a 12-month temporary contract. As a key member of the regulatory team, you will provide strategic guidance and support to ensure compliance with global regulatory requirements.Key Responsibilities:Develop and maintain...
-
Regulatory Affairs Manager
4 weeks ago
Uxbridge, United Kingdom Park Street People Full timeRegulatory Affairs Manager OpportunityPark Street People Ltd is seeking a highly skilled Regulatory Affairs Manager to join their team on a 12-month temporary contract. As a key member of the regulatory team, you will provide strategic guidance and support to ensure compliance with global regulatory requirements.Key Responsibilities:Develop and maintain...
-
Regulatory Affairs Manager
3 weeks ago
Uxbridge, United Kingdom Park Street People Full timePark Street People Ltd is seeking a Regulatory Affairs Manager to provide strategic guidance and support to their team. The ideal candidate will have experience in regulatory affairs and compliance, particularly in the pharmaceutical industry.The successful candidate will be responsible for developing and implementing regulatory strategies, ensuring...
-
Regulatory Affairs Manager
2 months ago
Uxbridge, United Kingdom CV-Library Full timeAn innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and early stage development experience to join their team on a 12 month temporary contract. Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the...
-
Global Regulatory Sciences Director
3 weeks ago
Uxbridge, United Kingdom Bristol Myers Squibb Full timeTransforming Lives through Regulatory ExcellenceBristol Myers Squibb is a company that pushes the boundaries of what's possible in the world of pharmaceuticals. As an Associate Director, Global Regulatory Sciences, Precision Medicine, you'll be at the forefront of this innovation, driving regulatory strategies that bring life-changing treatments to patients...
-
Regulatory Affairs Director
3 weeks ago
Uxbridge, United Kingdom Regeneron Full timeThe Director of Regulatory Affairs will provide strategic leadership on global regulatory activities for assigned products. Responsibilities will focus on Clinical Regulatory filings and provide regulatory guidance on project teams in this area. We are a hands-on culture, so responsibilities will include support to some clinical study activities.Key...
-
Strategic Regulatory Affairs Director
6 days ago
Uxbridge, United Kingdom Bristol Myers Squibb Full timeAbout the RoleThis role will lead the development of regulatory strategies to support the development of biomarkers, companion diagnostic tests, digital health, and other devices to enhance the value of our pharmaceutical products across therapeutic areas.ResponsibilitiesLead global regulatory strategy development and implementation.Collaborate with...
-
Director, Global Regulatory Lead
4 weeks ago
Uxbridge, United Kingdom Bristol Myers Squibb Full timeTransforming Patients' Lives through ScienceBristol Myers Squibb is a leading biopharmaceutical company that is dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Director, Global Regulatory Lead to join our team.Job SummaryThe Director, Global Regulatory Lead will be responsible for leading the...
-
Regulatory Affairs Specialist
4 weeks ago
Uxbridge, United Kingdom Regeneron Full time{"title": "CMC Regulatory Affairs Specialist", "description": "Job SummaryWe are seeking a highly skilled CMC Regulatory Affairs Specialist to join our team at Regeneron. As a key member of our regulatory team, you will be responsible for ensuring the compliance of our global regulatory and CMC submissions.Key ResponsibilitiesReview and assess regulatory...
-
Regulatory Affairs Specialist
4 weeks ago
Uxbridge, United Kingdom Regeneron Full time{"title": "CMC Regulatory Affairs Specialist", "description": "Job SummaryWe are seeking a highly skilled CMC Regulatory Affairs Specialist to join our team at Regeneron. As a key member of our regulatory team, you will be responsible for ensuring the compliance of our global regulatory and CMC submissions.Key ResponsibilitiesReview and assess regulatory...
-
Regulatory Affairs Specialist
3 weeks ago
Uxbridge, United Kingdom Lifelancer Full timeSenior Regulatory Affairs Manager - CMCLifelancer is seeking a highly experienced Senior Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines.This is a challenging role that offers the opportunity to work on diverse...
-
Global Regulatory Sciences Director
3 weeks ago
Uxbridge, United Kingdom Bristol Myers Squibb Full timeTransforming Lives through Regulatory ExcellenceBristol Myers Squibb is a leader in the pharmaceutical industry, and we're seeking a talented individual to join our team as a Global Regulatory Sciences Director. In this role, you'll have the opportunity to work on cutting-edge projects that transform the lives of patients worldwide.Key...