Senior Regulatory Affairs Manager - Central Regulatory Affairs (CRA), Europe
Core
Lead a high-performing team of Regulatory professionals and oversee the European regulatory strategy for a diverse portfolio of medicinal products (Generic, Established Brand, Innovative, Value-Added) to ensure successful product lifecycle management and market access.
Role type
Senior Regulatory Affairs Manager (Central Regulatory Affairs)
Builds
European regulatory strategies, product registrations (CP, DCP, MRP, National), and post-approval lifecycle activities for medicinal products.
Domain
Healthcare / Pharmaceuticals / Regulatory Affairs
Required skills
People management, European regulatory strategy, product lifecycle management, health authority engagement, risk mitigation, due diligence, cross-functional partnership
Preferred skills
Masters in Regulatory Affairs
Technologies
EMA, CP, DCP, MRP, Article 61(3)
Responsibilities
Lead and mentor a team of Regulatory professionals; Develop and implement European regulatory strategy; Manage new product registrations via Centralised, Decentralised, Mutual Recognition, and National procedures; Liaise with health authorities (EMA, national competent authorities); Ensure on-time submission of post-approval lifecycle activities; Partner with internal departments (Clinical, Quality, Legal, Commercial) and external BD partners.
Seniority
Senior, hands-on IC with people management