Senior Manager, Global Regulatory Affairs
Posted 6 days ago by Planet Pharma
Negotiable
Undetermined
Undetermined
Maidenhead, England, United Kingdom
Summary: The Senior Manager, Global Regulatory Affairs role at a global biopharmaceutical company focuses on supporting the lifecycle management of key marketed products in International Growth Markets. The position requires strategic involvement in submission strategies and compliance across diverse markets, with an emphasis on collaboration with global stakeholders. Candidates should have 3–5+ years of regulatory affairs experience, particularly in emerging markets. This role offers high visibility and the opportunity to impact healthcare access in underserved regions.
Key Responsibilities:
- Support lifecycle management of key marketed products in International Growth Markets.
- Play a strategic role in shaping submission strategies and ensuring compliance.
- Collaborate with global stakeholders on cross-functional project teams.
- Prepare New Drug Application (NDA) submissions for countries within the IGM region.
- Represent the region and the International/Global Markets (IGM) group effectively.
Key Skills:
- Minimum of 5 years of experience in the pharmaceutical or biotechnology industry.
- Focus on Regulatory Affairs, preferably within International or Emerging Markets.
- Proven ability to represent the region on cross-functional project teams.
- Strong understanding of international regulatory requirements and processes.
Salary (Rate): undetermined
City: Maidenhead
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Planet Pharma are currently working on an exciting opportunity with a global biopharmaceutical company that’s looking to expand its Regulatory Affairs team. The role focuses on International Growth Markets, supporting the lifecycle management of key marketed products. As a key member of the global regulatory project team, you’d play a strategic role in shaping submission strategies and ensuring compliance across diverse markets. If you have 3–5+ years’ experience in regulatory affairs, particularly in emerging markets, and enjoy cross-functional collaboration with global stakeholders, this could be a fantastic next step.
Requirements:
- Minimum of 5 years of experience in the pharmaceutical or biotechnology industry, with a focus on Regulatory Affairs—preferably within International or Emerging Markets.
- Proven ability to effectively represent the region and the International/Global Markets (IGM) group on cross-functional project teams.
- Demonstrated experience in preparing New Drug Application (NDA) submissions for countries within the IGM region.
- Strong understanding of international regulatory requirements and processes.
The position offers a truly international scope, high visibility, and the chance to contribute to meaningful healthcare access across underserved regions. For more information or to apply, please contact Ollie at Planet Pharma at Oloveland@planet-pharma.co.uk