Amgen is seeking an EU Regulatory Affairs Manager for Biosimilars based in the UK or Portugal. You will contribute to development and execution of regulatory strategies across EU submissions, from development through launch and lifecycle management.
You will collaborate with CMC, Clinical, Safety, Quality, Legal and Commercial, lead health authority interactions, manage MAAs and post-approval changes, and monitor EU biosimilar policy.
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EU Biosimilars Regulatory Lead – Strategy & Submissions in Cambridge employer: Amgen
At Amgen, we pride ourselves on being a leading biotechnology company that prioritises the well-being and growth of our employees. As an EU Regulatory Affairs Manager, you will be part of a diverse and inclusive team dedicated to serving patients, with ample opportunities for professional development and a generous Total Rewards Plan. With flexible working arrangements from our offices in Cambridge, Uxbridge, or Lisbon, you can enjoy a fulfilling career while maintaining a healthy work-life balance.
