EU Regulatory Affairs Manager
Core
Ensure Amgen acquires and maintains required EU licenses to support clinical trials and marketed medicinal products.
Role type
EU Regulatory Affairs Manager
Builds
EU regulatory submissions (clinical trial and marketing applications) and product lifecycle strategies
Domain
Biotechnology / Pharmaceuticals
Required skills
EU registration procedures, regulatory strategy development, EU legislation knowledge, SOP management, conflict resolution, AI tool proficiency
Preferred skills
Experience with scientific advice, orphan applications, Paediatric Investigation Plans (PIPs), post-approval changes
Technologies
AI tools
Responsibilities
Plan and manage regulatory submissions in compliance with EU requirements; implement product-related regulatory strategies; provide content guidance for regional regulatory documents; support EU label negotiation activities; maintain awareness of new EU legislation and regulatory policy; perform regulatory research to obtain relevant histories and precedences.
Seniority
Experienced professional