Senior Manager, Global Regulatory Affairs

JR United Kingdom; Slough; Hybrid; GBP 65,000 - 90,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Senior Manager in Global Regulatory Affairs based in Slough. This role involves developing regulatory strategies, liaising with health authorities, and leading submissions for global programs. The successful candidate will have extensive experience in the pharmaceutical industry and a proven track record in Regulatory Affairs, ideally with an advanced degree in a relevant scientific field. This hybrid position offers the opportunity to contribute to strategies that positively impact patient lives.

Qualifications

• Significant experience in the pharmaceutical industry including 5+ years in Regulatory Affairs.
• In-depth knowledge of global health authority requirements (FDA, EMA, ICH).
• Experience in global submissions, regulatory meetings, and lifecycle management.

Responsibilities

• Develop and implement regulatory strategies for assigned programs.
• Lead planning and execution for global submissions and consultations.
• Identify regulatory risks and propose mitigation strategies.

Skills

Communication

Negotiation

Collaboration

Education

Advanced degree in a relevant scientific discipline

Job description

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Senior Manager, Global Regulatory Affairs, slough

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Client:

Meet Life Sciences

Location:

slough, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

4

Posted:

31.05.2025

Expiry Date:

15.07.2025

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Job Description:

Senior Manager, Global Regulatory Affairs

Location: Hybrid – UK (Paddington)

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 a unique opportunity to join a growing function with global scope.

As a Senior Manager in Global Regulatory Affairs, you will be accountable for regulatory strategy, submissions, and lifecycle management across international programs. You'll work cross-functionally with R&D, franchise, operations, and commercial teams while serving 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 primary regulatory interface across internal functions and regulatory authorities
• Provide strategic regulatory input into target product profiles and integrated asset plans
• Lead planning and execution for global submissions and health authority consultations
• Identify regulatory risks and propose mitigation strategies to project teams and senior leadership
• Monitor regulatory trends and competitor activity relevant to the assigned therapeutic areas
• Build and maintain strong relationships with global regulators to support strategy alignment
• Drive process improvements and operational excellence within the GRA function
• Ensure alignment with ethical standards and global regulatory compliance
• Contribute to regulatory due diligence for business development opportunities

Required Qualifications

• Advanced degree (or equivalent) in a relevant scientific discipline (e.g. Pharmacy, Medicine, Chemistry, Biological Sciences)
• Significant experience in the pharmaceutical industry, including 5+ years in Regulatory Affairs
• Proven success in leading global drug development and regulatory strategies
• In-depth knowledge of global health authority requirements (e.g. FDA, EMA, ICH)
• Strong communication, negotiation, and cross-functional collaboration skills
• Experience in global submissions, regulatory meetings, and lifecycle management

Preferred Qualifications

• Background in rare diseases, drug-device combinations, or medical devices
• Familiarity with global regulatory frameworks and international health authority interactions
• Experience influencing external stakeholders (e.g. regulators, industry groups)
• Comfortable working in a hybrid and global matrix team environment

Additional Information

• Hybrid model: ~3 days per week onsite in Paddington (UK)

This is an exciting opportunity to join a highly collaborative, innovation-driven environment and contribute to global regulatory strategies that impact patient lives worldwide. If you're an experienced regulatory professional seeking your next challenge, we'd love to hear from you.