Regulatory Affairs Manager - Central Regulatory Affairs (CRA), Europe
Core
Lead and support regulatory strategy and execution across European markets for a diverse portfolio of medicinal products including Generic, Established Brand, Innovative, and Value-Added products.
Role type
Senior Regulatory Affairs Manager (Central)
Builds
European regulatory strategies, product registrations, and lifecycle management for medicinal products
Domain
Healthcare / Pharmaceuticals / Regulatory Affairs
Required skills
Regulatory strategy, EU and national requirements compliance, Centralised Procedure (CP), Decentralised Procedure (DCP), Mutual Recognition Procedure (MRP), post-approval lifecycle management, Health Authority engagement, risk mitigation, mentoring
Preferred skills
Masters in Regulatory Affairs
Technologies
EMA, Article 61(3), CMC, Pharmacovigilance
Responsibilities
Lead regulatory strategy for European markets, manage new product registrations via CP/DCP/MRP, prepare post-approval submissions (Renewals, Variations), liaise with Health Authorities, partner with internal departments (Clinical, Quality, Legal, Commercial), assess regulation changes and develop risk mitigation strategies, provide mentoring to team members
Seniority
Senior, hands-on IC with mentorship responsibilities