United States Regulatory Manager – Obesity And Related Conditions

Amgen Inc

Base: $112,744.00 - $152,536.00 usd annually; bonu...
Execute u.s. regulatory strategy
Manage fda submissions
Ensure patient safety compliance
This role ensures Amgen acquires and maintains required U.S. licenses to support clinical trials and marketed products while prioritizing patient safety

Job Summary

  • This role ensures Amgen acquires and maintains required U.S. licenses to support clinical trials and marketed products while prioritizing patient safety.
  • The successful candidate will develop and execute U.S. regulatory strategies, manage submissions aligned with global plans, and provide guidance on regulatory pathways.
  • Amgen offers a comprehensive benefits package including retirement savings, health coverage, stock-based incentives, and flexible work models.

Matching Summary

This role ensures Amgen acquires and maintains required U.S. licenses to support clinical trials and marketed products while prioritizing patient safety.

Salary

Base: $112,744.00 - $152,536.00 USD annually; Bonus/Equity: Discretionary annual bonus and stock-based long-term incentives; Benefits: Comprehensive health, dental, vision, retirement plan, and flexible time-off

Skills & Requirements

Must-have

  • Execute U.S. regulatory strategy
  • Manage FDA submissions
  • Ensure patient safety compliance
  • Support labeling development
  • Interact with regulatory agencies

Nice-to-have

  • Experience in obesity therapeutic areas
  • Strong cross-functional collaboration skills
  • Ability to influence without authority
  • Knowledge of expedited programs
  • Cultural awareness for global teams

Key Requirements

  • Doctorate degree OR Master's with 2 years experience
  • Bachelor's degree with 4 years experience
  • Direct experience with FDA interactions
  • Understanding of U.S. drug registration pathway
  • Working knowledge of U.S. medicinal legislation

Work Rights

Not specified

Tailored Resume

Cover Letter