Senior Associate Regulatory Affairs
AmgenCambridge, England, United Kingdom • London, England, United Kingdom
Posted April 22, 2026
Full Time
About the Company
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes. For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads. 🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines 🔗Global Privacy Statement Directory: www.amgen.com/dp Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
Job Description
We are seeking a Senior Associate Regulatory Affairs to support and lead in the local coordination and execution of regulatory submissions in compliance with Amgen corporate standards and national regulatory requirements, as well as Regulatory Affairs processes and deliverables for the UK and Ireland. The role involves ensuring regulatory submissions are made on time, collating and distributing regulatory information, and reviewing promotion and non-promotion materials to ensure compliance with local licence, company procedures and Code of Practice.
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
