Senior Manager, Regulatory Affairs
Core
Senior Manager leading the UK Regulatory Affairs team for a specific therapeutic area, ensuring MHRA compliance and driving product lifecycle strategies.
Role type
Senior Manager, Regulatory Affairs (Line Management)
Builds
Regulatory strategies, submissions, and team capabilities for pharmaceutical product launches
Domain
Pharmaceuticals / Neuroscience / UK Regulatory Landscape
Deliverable
client delivery | dashboards & analysis
Required skills
UK regulatory strategy, MHRA liaison, team leadership, recruitment, performance management, regulatory intelligence, compliance auditing, cross-functional alignment
Preferred skills
Experience with clinical trial submissions, variations, PIPs, NMAAs, trade association engagement, process improvement
Technologies
None explicitly stated
Responsibilities
Provide line management for the UK Regulatory team including recruitment and talent development; oversee regulatory submissions to MHRA; develop regulatory strategies for product lifecycle; ensure compliance with UK legislation and ABPI code; act as primary contact for audits and inspections; liaise with internal stakeholders and external health authorities
Seniority
Senior, hands-on IC with people management
