Senior Associate Regulatory Affairs

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. 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. It’s time for a career you can be proud of. Join us.

SENIOR ASSOCIATE REGULATORY AFFAIRS - UK & IRELAND

In this vital role you will support and, where appropriate, lead in the local coordination and execution of regulatory submissions in compliance with Amgen corporate standards and national regulatory requirements, as well as Regulatory Affairs processes and deliverables for the UK and Ireland.

• Ensure regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements and support licence and clinical trials activities
• Contribute to and execute local filing plans
• Act as a key contact for agency interactions for an assigned portfolio of products
• Collate, distribute, exchange and archive regulatory information with colleagues across the business
• Participate in regulatory and affiliate process improvements initiatives
• Review promotion and non‑promotion materials to ensure compliance with local licence, company procedures and Code of Practice

What We Expect Of You

We seek an experienced professional who meets the following qualifications and skills:

• Degree educated
• Experience in the management of marketing authorisations in the UK and the EU
• Experience with developing and maintaining clinical trial documentation in the UK and the EU (e.g. IMPDs, IMPD amendments) and ability to work with increasing autonomy
• Knowledge and awareness of the relevant regulatory guidelines and legislation
• Strong communication skills both oral and written
• Organisational skills and demonstrated regulatory project management skills
• Experience with Veeva Vault

What You Can Expect Of Us

• Vast opportunities to learn and move up and across our global organisation
• 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: Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, 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.

#J-18808-Ljbffr