Job Title

Senior Manager, Global Regulatory Affairs Location: Hybrid – UK (Paddington)Employment Type: Full-timeAbout the RoleWe 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 ResponsibilitiesDevelop and implement regulatory strategies for assigned programs at regional or global levelsServe as the primary regulatory interface across internal functions and regulatory authoritiesProvide strategic regulatory input into target product profiles and integrated asset plansLead planning and execution for global submissions and health authority consultationsIdentify regulatory risks and propose mitigation strategies to project teams and senior leadershipMonitor regulatory trends and competitor activity relevant to the assigned therapeutic areasBuild and maintain strong relationships with global regulators to support strategy alignmentDrive process improvements and operational excellence within the GRA functionEnsure alignment with ethical standards and global regulatory complianceContribute to regulatory due diligence for business development opportunitiesRequired QualificationsAdvanced 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 AffairsProven success in leading global drug development and regulatory strategiesIn-depth knowledge of global health authority requirements (e.g. FDA, EMA, ICH)Strong communication, negotiation, and cross-functional collaboration skillsExperience in global submissions, regulatory meetings, and lifecycle managementPreferred QualificationsBackground in rare diseases, drug-device combinations, or medical devicesFamiliarity with global regulatory frameworks and international health authority interactionsExperience influencing external stakeholders (e.g. regulators, industry groups)Comfortable working in a hybrid and global matrix team environmentAdditional InformationStandard Monday–Friday scheduleHybrid 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.