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 generics, established brands, and innovative products.
Role type
Senior Regulatory Affairs Manager (Central Regulatory Affairs)
Builds
European regulatory strategies, product registrations, and license maintenance for global and local portfolios.
Domain
Healthcare / Pharmaceuticals / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy development, EU and national requirements compliance, new product registration management, health authority engagement, risk mitigation planning, mentoring and training
Preferred skills
Masters in Regulatory Affairs
Technologies
Centralised Procedure (CP), Decentralised Procedure (DCP), Mutual Recognition Procedure (MRP)
Responsibilities
Lead regulatory strategy for European markets, manage new product registrations via EU procedures, liaise with health authorities like EMA, support assessment of regulation changes, provide mentoring to team members
Seniority
Senior, hands-on IC with mentorship responsibilities
