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Regulatory Affairs Specialist

2 months ago

Uxbridge, United Kingdom Amgen Inc. (IR) Full time
Senior Associate Regulatory Affairs - UK & Ireland

Career Category: Regulatory

SENIOR ASSOCIATE REGULATORY AFFAIRS - UK & IRELAND

We are seeking a highly skilled Senior Associate Regulatory Affairs professional to join our team in the UK and Ireland. As a key member of our regulatory affairs team, you will play a critical role in ensuring the timely submission of regulatory documents and supporting license and clinical trials activities.

Key Responsibilities:

  • Develop and implement local filing plans to ensure compliance with Amgen's corporate and local regulatory requirements.
  • Coordinate and review briefing documents and/or other submissions for meetings with Regulatory agencies.
  • 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 license, company procedures, and Code of Practice.

Requirements:

  • Knowledge and awareness of relevant regulatory guidelines and legislation.
  • Organizational skills and developing regulatory project management skills.
  • Able to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.

About Amgen:

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.