Senior Manager, Global Regulatory Affairs

JR United Kingdom; Bedford; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Senior Manager for Global Regulatory Affairs in Bedford. This role is key in shaping submission strategies and ensuring compliance for products in International Growth Markets. Candidates should have 5+ years of regulatory affairs experience and a strong understanding of international requirements.

Qualifications

• Minimum of 5 years of experience in the pharmaceutical or biotechnology industry.
• Experience in preparing New Drug Application (NDA) submissions.
• Strong understanding of international regulatory processes.

Responsibilities

• Play a strategic role in shaping submission strategies.
• Ensure compliance across diverse international markets.
• Support lifecycle management of key marketed products.

Skills

Cross-functional collaboration

Regulatory Affairs

International regulatory requirements

Job description

Senior Manager, Global Regulatory Affairs, Bedford

Planet Pharma is 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 [emailprotected].