Requirements: English
Company: Meet Life Sciences
Region: le-de-France
Senior Manager, Global Regulatory Affairs
Location: Hybrid France (Boulogne)
Employment Type: Full-time
About the Role
We are partnering with a global biopharmaceutical company to support the hire of a Senior Manager within their Global Regulatory Affairs (GRA) team. These hires follow an internal move and a recent resignation, presenting an exciting opportunity to join a growing function with international scope.
As a Senior Manager in Global Regulatory Affairs, you will be accountable for regulatory strategy, submissions, and lifecycle management across global programs. Youll work closely with cross-functional teams in RD, franchise, operations, and commercial while acting as a key liaison with health authorities worldwide.
Key Responsibilities
- Develop and implement regulatory strategies for assigned programs at regional or global levels
- Serve as the main regulatory point of contact across internal teams and external regulators
- Provide strategic input into target product profiles, clinical development, and asset plans
- Plan and lead global submissions and regulatory interactions (e.g. Scientific Advice, FDA meetings)
- Identify regulatory risks and develop mitigation strategies
- Monitor regulatory trends and competitor activity relevant to assigned therapeutic areas
- Build relationships with regulators to support long-term strategic alignment
- Drive operational excellence within the regulatory function
- Ensure global compliance and alignment with ethical standards
- Support due diligence efforts for external opportunities
Required Qualifications
- Advanced degree (or equivalent) in a scientific discipline (e.g. Pharmacy, Medicine, Chemistry, Biological Sciences)
- Significant experience in the pharmaceutical industry, including 7+ years in Regulatory Affairs
- Proven ability to lead global regulatory strategy and manage complex projects
- In-depth understanding of ICH, FDA, EMA, and international regulatory frameworks
- Experience preparing and executing global submissions and health authority engagements
- Strong project management, communication, and cross-functional leadership skills
Preferred Qualifications
- Experience in rare diseases, drug-device combinations, or medical devices
- Familiarity with global regulatory frameworks and submission processes
- Prior involvement in external influencing activities or trade associations
- Comfortable working in a hybrid and matrix team environment
Additional Information
- Standard MondayFriday schedule
- Hybrid model: ~3 days per week onsite in Boulogne, France
This is a unique opportunity to join an organisation focused on innovation and patient outcomes. If you have strong regulatory experience and are looking for your next challenge in a globally visible role, wed love to hear from you.
Apply now to learn more.