About this role
EU Regulatory Affairs Manager (Biosimilars)
In this vital role you will contribute to the development and execution of European regulatory strategies for Amgen’s biosimilar portfolio, supporting products from development and registration through launch and lifecycle management.
- Plan and manage EU/EEA regulatory submissions, including MAAs, responses to Health Authorities, CTAs/CTIS activities and post-approval lifecycle submissions.
- Partner with global and regional cross-functional teams, including CMC, Clinical, Safety, Quality, Legal and Commercial.
- Lead and support Health Authority interactions, including preparation of briefing materials, regulatory responses and follow-up actions.
- Support product information and labelling activities, including SmPC, Package Leaflet, artwork and regional label negotiations.
- Ensure regulatory compliance and maintenance of filings throughout development and the product lifecycle.
- Monitor evolving EU biosimilar legislation, guidance, regulatory policy and competitor intelligence, assessing potential impact on regulatory strategies.
- Contribute to regulatory processes, SOPs, templates and continuous improvement initiatives.
Be part of our team
We are currently looking for a Regulatory Affairs Manager based in either Portugal or the United Kingdom.
You would be joining the European Regulatory Team, part of the Global Regulatory Affairs function in Europe. You would be working with colleagues who are responsible for leading the European regulatory strategies and submissions for development and marketed products from clinical trials to marketing authorisation, and throughout the products lifecycle.
WIN
What we expect of you
- Degree educated.
- Knowledge of drug development for Biosimilars within a regional regulatory environment including direct experience with EU biosimilar submissions and post-approval maintenance.
- Proven experience wo