EU Regulatory Affairs Manager

Overview

In this EU Regulatory Affairs Manager role, you help secure and maintain EU licenses for clinical trials and marketed products, supporting one or more products from an EU regulatory perspective. You may lead regulatory activities for multiple products, coordinating submissions and strategy across Amgen’s Europe portfolio. You’ll craft regional regulatory plans, guide documents and meetings, and navigate legislation to accelerate development and market access. The position offers flexibility to work remotely with occasional office days, and opportunities to grow within a global regulatory team committed to patients.

Pay / Benefits

• generous total rewards plan (health, finance, work/life balance)
• flexible/hybrid work arrangement
• growth and career development opportunities
• diverse and inclusive culture
• global collaboration and exposure
• remote-friendly with occasional office days

Responsibilities

• Plan and manage regulatory submissions (clinical trial and marketing applications) in line with global plans and EU requirements
• Implement product-specific regulatory strategies and processes under supervision
• Provide regional regulatory guidance for documents and meetings in line with global strategy
• Advise on regional regulatory mechanisms to optimize development (e.g., FIH expediting, Orphan Drug, Paediatric plans)
• Support EU label negotiations and contribute to regional product strategies
• Develop predictions for regulatory outcomes and risks with input from regulatory agencies
• Conduct regulatory research on new legislation, policy, and guidance relevant to Amgen products
• Communicate regulatory impact of regional changes and competitor labeling under supervision

Key requirements

• Degree educated and prior experience in a similar regulatory role
• Hands-on experience with regional registration procedures (clinical trials, MA procedures, post-approval changes, renewals)
• Experience developing regulatory strategies for both clinical development and post-marketing phases
• Knowledge of EU legislation and regulations relating to medicinal products
• Experience with SOPs and policies; strong written and oral communication
• Ability to anticipate issues and resolve conflicts
• Basic proficiency in using AI tools to support day-to-day work

• strong communication skills (oral and written)
• ability to anticipate and prevent issues
• conflict resolution and action planning
• EU regulatory knowledge
• regulatory strategy development
• clinical trial and MA submission planning

…