Senior Manager, Global Regulatory Affairs

Social network you want to login/join with:

Senior Manager, Global Regulatory Affairs, slough

col-narrow-left

Client:

Meet Life Sciences

Location:

slough, United Kingdom

Job Category:

Other

–

EU work permit required:

Yes

col-narrow-right

Job Views:

4

Posted:

31.05.2025

Expiry Date:

15.07.2025

col-wide

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.

#J-18808-Ljbffr