Senior Associate Regulatory Affairs

Amgen Inc

Cambridge, United Kingdom
Not specified; not specified; generous total rewar...
Hybrid (flexible work from home with regular office presence)
Degree educated professional
Experience managing uk/eu marketing authorisations
Knowledge of uk/eu clinical trial documentation
Amgen Inc is seeking a Senior Associate in Regulatory Affairs to support regulatory submissions and compliance for the UK and Ireland. The ideal candidate will have experience in managing marketing authorizations and clinical trial documentation, with a strong emphasis on communication and organizational skills

Job Summary

  • This role involves supporting and leading the local coordination and execution of regulatory submissions in compliance with Amgen corporate standards and national requirements.
  • The successful candidate will act as a key contact for agency interactions for an assigned portfolio of products while ensuring timely regulatory filings.
  • Amgen offers vast opportunities to learn and move up within a global organization that values diverse and inclusive communities.

Matching Summary

Match Score: 85

Amgen Inc is seeking a Senior Associate in Regulatory Affairs to support regulatory submissions and compliance for the UK and Ireland. The ideal candidate will have experience in managing marketing authorizations and clinical trial documentation, with a strong emphasis on communication and organizational skills.

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
  • Experience managing UK/EU marketing authorisations
  • Knowledge of UK/EU clinical trial documentation
  • Awareness of regulatory guidelines and 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
  • Passion for serving patients
  • Collaborative team player mindset
  • Commitment to process improvement initiatives

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter