Regulatory Policy And Intelligence Senior Manager

Amgen UK

Base: $141,588.75 - $191,561.25 usd annually; bonu...
Not specified (assumed to be flexible based on benefits mentioned).
In-depth regulatory experience in the u.s.
Knowledge of fda or ema regulations
Experience with ich activities
Amgen is seeking a Regulatory Policy and Intelligence Senior Manager who will support the development and implementation of regulatory policies affecting the company. The ideal candidate will have extensive experience in regulatory affairs, particularly with FDA or EMA, and will be responsible for engaging with various stakeholders and coordinating policy-related activities

Job Summary

  • This role supports the development and implementation of Amgen's positions on regulatory policies impacting the business.
  • The successful candidate will analyze emerging draft and final regulations to determine implications for the organization.
  • Amgen offers a comprehensive benefits package including retirement plans, health coverage, and stock-based incentives.

Matching Summary

Match Score: 85

Amgen is seeking a Regulatory Policy and Intelligence Senior Manager who will support the development and implementation of regulatory policies affecting the company. The ideal candidate will have extensive experience in regulatory affairs, particularly with FDA or EMA, and will be responsible for engaging with various stakeholders and coordinating policy-related activities.

Salary

Base: $141,588.75 - $191,561.25 USD annually; Bonus: Discretionary annual bonus program; Benefits: Comprehensive health, dental, vision, retirement plan, and stock incentives

Skills & Requirements

Must-have

  • In-depth regulatory experience in the U.S.
  • Knowledge of FDA or EMA regulations
  • Experience with ICH activities
  • Strong oral and written communication skills
  • Project management for policy objectives

Nice-to-have

  • Collaborative team player across functions
  • Ability to work in fast-paced environment
  • Diplomacy and conflict resolution skills
  • Experience with MS Office and Smartsheet
  • Scientific background degree preferred

Key Requirements

  • Doctorate or Master's degree with 6 years regulatory policy experience
  • Bachelor's degree with 8 years directly related experience
  • In-depth knowledge of U.S. legislation and medicinal product regulations

Work Rights

Not specified

Tailored Resume

Cover Letter