Eu Regulatory Affairs Senior Manager - General Medicine

Amgen Australia Pty Ltd

Cambridge, United Kingdom
**
Extensive regional regulatory experience
Proven track record in strategy execution
In-depth drug life cycle understanding
** Amgen Australia Pty Ltd is seeking a Senior Manager for EU Regulatory Affairs in General Medicine who will oversee regulatory submissions and strategy for clinical trials and marketed products. This fully remote position requires extensive experience in the regulatory environment and a degree in a scientific discipline. **

Job Summary

  • This role ensures Amgen acquires and maintains all required licenses for clinical trials and commercial products in the EU region.
  • The successful candidate will lead the development of regional regulatory strategies, including mechanisms for expediting studies and managing orphan drug designations.
  • Amgen offers growth opportunities within a diverse and inclusive community where teammates are empowered to bring ideas to the table.

Matching Summary

Match Score: 75

** Amgen Australia Pty Ltd is seeking a Senior Manager for EU Regulatory Affairs in General Medicine who will oversee regulatory submissions and strategy for clinical trials and marketed products. This fully remote position requires extensive experience in the regulatory environment and a degree in a scientific discipline. **

Skills & Requirements

Must-have

  • Extensive regional regulatory experience
  • Proven track record in strategy execution
  • In-depth drug life cycle understanding
  • Leadership of cross-functional teams
  • Strong stakeholder communication skills

Nice-to-have

  • Proactive problem solving approach
  • Ability to anticipate agency expectations
  • Dynamic environment adaptability
  • Collaborative team player mindset

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter