Eu Regulatory Affairs Senior Manager - General Medicine

Amgen Inc

Cambridge, UK
Fully remote
Extensive regional regulatory environment experience
Proven track record of developing regional regulatory strategy
In-depth understanding of drug life cycle and development process
Amgen Inc. is seeking an EU Regulatory Affairs Senior Manager for General Medicine, responsible for ensuring compliance with regional licensing and regulatory strategies for clinical trials and approved medicinal products. The role requires extensive experience in regulatory environments and offers opportunities for professional growth within a collaborative and inclusive company culture

Job Summary

  • This role ensures Amgen acquires and maintains all required licenses to support clinical trials and commercial operations in the EU.
  • The successful candidate will advise the Global Regulatory Team on regional considerations and implement strategies for product development and lifecycle management.
  • Amgen offers growth opportunities within a diverse and inclusive community dedicated to serving patients through innovative biotechnology solutions.

Matching Summary

Match Score: 85

Amgen Inc. is seeking an EU Regulatory Affairs Senior Manager for General Medicine, responsible for ensuring compliance with regional licensing and regulatory strategies for clinical trials and approved medicinal products. The role requires extensive experience in regulatory environments and offers opportunities for professional growth within a collaborative and inclusive company culture.

Skills & Requirements

Must-have

  • Extensive regional regulatory environment experience
  • Proven track record of developing regional regulatory strategy
  • In-depth understanding of drug life cycle and development process
  • Ability to lead teams in dynamic environment
  • Strong awareness of internal and external stakeholder needs

Nice-to-have

  • Proactive approach to problem solving
  • Ability to anticipate regulatory agency expectations
  • Experience with Orphan Drug and Fast Track mechanisms
  • Collaborative work style in global organization

Key Requirements

  • Degree educated in a scientific discipline
  • Extensive experience in regional regulatory environment
  • In-depth understanding of registration procedures for MA, post approval changes, extensions and renewals

Work Rights

Not specified

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