EU Regulatory Affairs Manager (Biosimilars)

Overview

In this role you contribute to EU regulatory strategies for Amgen’s biosimilar portfolio, guiding submissions from development to launch and lifecycle management. You will collaborate with global and regional teams to prepare MAAs, responses, and post-approval filings, while engaging Health Authorities. You’ll influence labeling, ensure regulatory compliance, and monitor evolving EU rules to refine strategies. This position offers impact across development and commercialization within a mission-driven biotech environment.

Pay / Benefits

• Growth opportunities to advance across the global organization
• Diverse and inclusive community
• Generous Total Rewards Plan (health, finance and wealth, work/life balance, career benefits)

Responsibilities

• Plan and manage EU/EEA regulatory submissions (MAAs, CTIS, responses to Health Authorities, post-approval submissions).
• Partner with global and regional cross-functional teams (CMC, Clinical, Safety, Quality, Legal, Commercial).
• Lead and support Health Authority interactions, including briefing materials and regulatory responses.
• Support product information and labeling activities (SmPC, Package Leaflet, artwork, regional label negotiations).
• Ensure regulatory compliance and maintenance of filings throughout development and lifecycle.
• Monitor EU biosimilar legislation and policy; assess impact on regulatory strategies.
• Contribute to regulatory processes, SOPs, templates, and continuous improvement initiatives.

Key requirements

• Degree educated.
• Knowledge of biosimilar drug development within a regional regulatory environment with EU submissions and post-approval maintenance.
• Experience with policies, procedures and SOPs.
• Awareness of registration procedures in region for clinical trials, MA, post-approval changes, extensions and renewals.
• Experience with EU Centralised Procedure and understanding of EU regulatory incentives.
• Strong oral and written communication skills.
• Ability to anticipate and prevent potential issues; resolve conflicts and define actionable paths.
• Experience in a global or matrixed organization with cross-regional collaboration.

• strong communication
• problem anticipation
• conflict resolution
• EU Centralised Procedure
• MAA submissions
• CTIS activities

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