Senior Regulatory Affairs Manager
Core
Lead regulatory strategy and submissions for a vaccines portfolio, managing marketing authorizations with UK and Irish health authorities and leading the annual seasonal strain change process.
Role type
Senior Regulatory Affairs Manager (Team Lead)
Builds
Vaccine marketing authorizations and regulatory lifecycle management for UK and Ireland
Domain
Biopharma / Vaccines
Required skills
Regulatory strategy, submission management, team leadership, stakeholder management, commercial planning, supply chain compliance, biologics lifecycle management
Preferred skills
AI-powered research collaboration, cross-functional collaboration
Technologies
None stated
Responsibilities
Lead preparation and submission of regulatory applications to UK and Irish health authorities; Own regulatory strategy for new approvals and ongoing changes; Lead the yearly seasonal flu vaccine update process; Ensure accuracy and timeliness of information sent to regulators; Advise on product positioning and promotion; Coach, develop, and manage a small team
Seniority
Senior, hands-on IC with people-leadership