Senior Manager, Global Regulatory Affairs

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

• Standard Monday–Friday schedule
• 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.

Apply now to learn more.