Senior Associate Regulatory Affairs

Support and lead local coordination and execution of regulatory submissions in compliance with Amgen corporate standards and national regulatory requirements for the UK and Ireland. Ensure regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements and support licence and clinical trials activities.

Requirements

• Degree educated
• Experience in the management of marketing authorisations in the UK and the EU
• Experience in/knowledge of developing and maintaining clinical trial documentation in UK and the EU (e.g. IMPDs, IMPD amendments) and ability to work with increasing autonomy
• Knowledge and awareness of the relevant regulatory guidelines and legislation
• Strong communication skills both oral and written
• Organisational skills & developing or demonstrated regulatory project management skills
• Experience with Veeva Vault

Benefits

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits