EU Biosimilars Regulatory Affairs Manager

Biopharma Careers

Uxbridge

Hybrid

GBP 42,000 - 57,000

Full time

14 days+

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Job summary

Amgen is seeking an EU Regulatory Affairs Manager - Biosimilars to develop and execute European regulatory strategies for biosimilar portfolio, from development through launch and lifecycle management.

You will lead EU/EEA submissions, interact with Health Authorities, and work with global/regional teams to ensure compliant labeling and lifecycle activities across Europe. The role offers flexible home-office options and regional collaboration across Portugal, UK, and Lisbon/Cambridge offices.

Qualifications

Degree educated with knowledge of drug development for biosimilars.
Experience with EU biosimilar submissions and post-approval maintenance.
Knowledge of EU Centralised Procedure and regulatory incentives.
Strong written and oral communication skills.

Responsibilities

Plan and manage EU/EEA regulatory submissions (MAAs, CTAs/CTIS) and lifecycle submissions.
Collaborate with global/regional functions (CMC, Clinical, Safety, Quality, Legal, Commercial).
Lead and support Health Authority interactions and regulatory responses.
Support labeling activities (SmPC, Package Leaflet, artwork) and regional label negotiations.
Ensure regulatory filings maintenance throughout development and lifecycle.