Eu Regulatory Affairs Senior Manager - General Medicine

Amgen UK

Cambridge, United Kingdom
**
Extensive regional regulatory experience
Drug life cycle understanding
Clinical trial and marketing applications
** Amgen UK is seeking a Senior Manager for EU Regulatory Affairs in General Medicine, responsible for managing regulatory submissions and strategies to support clinical trials and market approvals. The ideal candidate will have extensive experience in the regional regulatory environment and a strong understanding of the drug development process. **

Job Summary

  • This role ensures Amgen acquires and maintains all required licenses to support clinical trials and commercial products in the EU.
  • The successful candidate will lead the development of regional regulatory strategies, including expedited pathways like Orphan Drug and Fast Track designations.
  • Amgen offers growth opportunities within a diverse and inclusive community dedicated to serving patients through innovative biotechnology solutions.

Matching Summary

Match Score: 75

** Amgen UK is seeking a Senior Manager for EU Regulatory Affairs in General Medicine, responsible for managing regulatory submissions and strategies to support clinical trials and market approvals. The ideal candidate will have extensive experience in the regional regulatory environment and a strong understanding of the drug development process. **

Skills & Requirements

Must-have

  • Extensive regional regulatory experience
  • Drug life cycle understanding
  • Clinical trial and marketing applications
  • Health authority interaction management
  • Strategic planning for product development

Nice-to-have

  • Proactive problem solving approach
  • Collaborative team leadership skills
  • Ability to anticipate agency expectations
  • Strong stakeholder awareness
  • Dynamic environment adaptability

Key Requirements

  • Degree educated in a scientific discipline
  • In-depth understanding of registration procedures for MA and post-approval changes
  • Proven track record of executing regional regulatory strategy

Work Rights

Not specified

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