EU Regulatory Affairs Manager
Core
Ensure acquisition and maintenance of EU licenses to support clinical trials and marketed medicinal products; plan and manage regulatory submissions in compliance with EU requirements.
Role type
EU Regulatory Affairs Manager
Builds
Clinical trial and marketing applications for oncology and general medicine products
Domain
Biotechnology / EU Regulatory Affairs
Required skills
EU registration procedures, regulatory strategy development, EU legislation knowledge, SOP management, risk anticipation, conflict resolution, AI tool proficiency
Preferred skills
Experience with scientific advice, orphan applications, Paediatric Investigation Plans (PIPs), post-approval changes, label negotiation
Technologies
AI tools
Responsibilities
Plan and manage regulatory submissions for clinical trial and marketing applications; implement product-related regulatory strategies; provide regulatory guidance on regional mechanisms to optimize product development; 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
