Sr Mgr Regulatory Affairs

Amgen UK

United Kingdom
International regulatory strategy development
Regulatory product compliance
Global regulatory plans
Oversees regulatory compliance initiatives, ensuring adherence to state and federal regulatory requirements

Job Summary

  • Oversees regulatory compliance initiatives, ensuring adherence to state and federal regulatory requirements.
  • Develops international regulatory strategy and contributes to global regulatory plans for Amgen products.
  • Builds effective relationships and communication paths across global, regional, local, and functional organizations to enable efficiencies.

Matching Summary

Oversees regulatory compliance initiatives, ensuring adherence to state and federal regulatory requirements.

Skills & Requirements

Must-have

  • International regulatory strategy development
  • Regulatory product compliance
  • Global regulatory plans
  • Clinical trial submissions
  • Marketing authorization applications
  • Lifecycle management activities
  • Agency meeting discussions

Nice-to-have

  • Process improvement initiatives
  • Cultural awareness and sensitivity
  • Teamwork ability
  • Negotiation and influencing skills

Key Requirements

  • Doctorate OR Master’s degree (scientific area) and 6 years of directly related experience
  • Bachelor’s degree (scientific area) and 8 years of directly related experience
  • In-depth regulatory experience in the international regulatory environment

Work Rights

Not specified

Tailored Resume

Cover Letter