Regulatory Affairs Manager (Biotech) in Cambridge

It is key to our becoming one of the world's leading biotechnology companies.

We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide.

EU REGULATORY AFFAIRS MANAGER - BIOSIMILARSLIVEWhat you will do 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 Sm PC, 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.

Be part of our team We are currently looking for a Regulatory Affairs Manager based in either Portugal or the United Kingdom.

You would be joining the European Regulatory Team, part of the Global Regulatory Affairs function in Europe.

You would be working with colleagues who are responsible for leading the European regulatory strategies and submissions for development and marketed products from clinical trials to marketing authorisation, and throughout the products lifecycle.

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.

Experience with EU Centralised Procedure and understanding of EU regulatory incentives.

THRIVEWhat you can expect of us 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 LOCATION: Flexibility to work from home with few days per month working from our Cambridge, Uxbridge or Lisbon office.

For candidates based in the UK, compensation will be aligned with the local market and role requirements, with further details discussed during the recruitment process. com Equal Opportunity Statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request an accommodation..

• United Kingdom - Remote; United Kingdom - Cambridge
• Type: Full time