Senior Associate Regulatory Affairs

Amgen

Cambridge, United Kingdom
Not specified; not specified; generous total rewar...
Hybrid (flexible work from home with regular office work in cambridge or uxbridge)
Degree educated professional
Management of uk/eu marketing authorisations
Clinical trial documentation experience impds
Amgen is seeking a Senior Associate in Regulatory Affairs to support regulatory submissions in the UK and Ireland. The ideal candidate will have relevant regulatory experience, strong communication skills, and the ability to work autonomously

Job Summary

  • This role supports the local coordination and execution of regulatory submissions for the UK and Ireland while ensuring compliance with corporate standards.
  • The successful candidate will act as a key contact for agency interactions and review promotion materials to ensure adherence to local codes of practice.
  • Amgen offers vast opportunities to learn and move up within a diverse and inclusive community dedicated to developing treatments that take care of others.

Matching Summary

Match Score: 85

Amgen is seeking a Senior Associate in Regulatory Affairs to support regulatory submissions in the UK and Ireland. The ideal candidate will have relevant regulatory experience, strong communication skills, and the ability to work autonomously.

Salary

Not specified; Not specified; Generous Total Rewards Plan comprising health, finance, wealth, work/life balance, and career benefits

Skills & Requirements

Must-have

  • Degree educated professional
  • Management of UK/EU marketing authorisations
  • Clinical trial documentation experience IMPDs
  • Knowledge of regulatory guidelines legislation
  • Strong oral and written communication skills
  • Organisational and project management skills
  • Experience with Veeva Vault

Nice-to-have

  • Ability to work with increasing autonomy
  • Participation in process improvement initiatives
  • Collaborative global team environment
  • Commitment to serving patients mission

Key Requirements

  • Degree education required
  • Experience managing UK and EU marketing authorisations
  • Experience maintaining clinical trial documentation (IMPDs)
  • Knowledge of relevant regulatory guidelines and legislation
  • Experience with Veeva Vault software

Work Rights

Not specified

Tailored Resume

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