EU Regulatory Affairs Manager (Biosimilars)

About the role

Amgen is looking for an EU Regulatory Affairs Manager (Biosimilars) to join its European Regulatory Team, part of the Global Regulatory Affairs function in Europe. The role contributes to developing and executing European regulatory strategies for Amgen's biosimilar portfolio, covering development, registration, launch and lifecycle management. Candidates are based in either Portugal or the United Kingdom.

Key responsibilities

• 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 such as CMC, Clinical, Safety, Quality, Legal and Commercial.
• Lead and support Health Authority interactions, including briefing materials, regulatory responses and follow-up actions.
• Support product information and labelling, including SmPC, Package Leaflet, artwork and regional label negotiations.
• Ensure regulatory compliance and maintain filings throughout the product lifecycle.
• Monitor EU biosimilar legislation, guidance, regulatory policy and competitor intelligence, and assess their impact on regulatory strategy.
• Contribute to regulatory processes, SOPs, templates and continuous improvement initiatives.

Required profile

• Degree-educated candidate.
• Knowledge of biosimilar drug development in a regional regulatory environment, including direct experience with EU biosimilar submissions and post-approval maintenance.
• Proven experience with policies, procedures and SOPs.
• Awareness of registration procedures for clinical trials, marketing authorisation, post-approval changes, extensions and renewals.
• Experience in a global or matrixed organisation with collaboration across regions.

Required skills

• Experience with the EU Centralised Procedure and understanding of EU regulatory incentives.
• Strong oral and written communication skills.
• Ability to anticipate and prevent issues, resolve conflicts and drive beneficial outcomes.

What we offer

• Growth opportunities to learn and move up and across the global organisation.
• A generous total rewards plan covering health, finance and wealth, work/life balance and career benefits.
• Flexibility to work from home with a few days per month in the Cambridge, Uxbridge or Lisbon office.
• Expected gross pay in Portugal of EUR 48,957 to EUR 66,237; UK pay is aligned with the local market and discussed during recruitment.