EU Regulatory Affairs Manager (Biosimilars)

In this vital role you will contribute to the development and execution of European regulatory strategies for Amgen’s biosimilar portfolio, supporting products from development and registration through launch and lifecycle management.

• 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, including CMC, Clinical, Safety, Quality, Legal and Commercial.
• Lead and support Health Authority interactions, including preparation of briefing materials, regulatory responses and follow-up actions.
• Support product information and labelling activities, including SmPC, Package Leaflet, artwork and regional label negotiations.
• Ensure regulatory compliance and maintenance of filings throughout development and the product lifecycle.
• Monitor evolving EU biosimilar legislation, guidance, regulatory policy and competitor intelligence, assessing potential impact on regulatory strategies.
• Contribute to regulatory processes, SOPs, templates and continuous improvement initiatives.

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced  professional, are these qualifications and skills:

• Degree educated.
• Knowledge of drug development for Biosimilars within a regional regulatory environment including direct experience with EU biosimilar submissions and post-approval maintenance.
• Proven experience working with policies, procedures and SOP’s.
• Awareness of the 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 communication skills - both oral and written.
• Ability to anticipate and prevent potential issues.
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
• Experience in a global or matrixed organization with collaboration across multiple regions.

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Growth opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits