United States Regulatory Manager – Obesity And Related Conditions

Amgen UK

Base: $112,744.00 - $152,536.00 usd annually; bonu...
Execute u.s. regulatory strategy
Manage fda submissions
Ensure patient safety compliance
The role focuses on acquiring and maintaining U.S. licenses to support clinical trials and marketed products while ensuring strict regulatory compliance

Job Summary

  • The role focuses on acquiring and maintaining U.S. licenses to support clinical trials and marketed products while ensuring strict regulatory compliance.
  • Candidates will lead U.S. regulatory execution, manage submissions aligned with global plans, and provide guidance on mechanisms like orphan designations.
  • Amgen offers a comprehensive benefits package including retirement savings, health coverage, stock incentives, and flexible work models.

Matching Summary

The role focuses on acquiring and maintaining U.S. licenses to support clinical trials and marketed products while ensuring strict regulatory compliance.

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 area
  • 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 + 2 years experience
  • Bachelor's degree + 4 years directly related experience
  • Experience interacting with FDA
  • Working knowledge of U.S. legislation/regulations
  • Understanding of drug development pathway

Work Rights

Not specified

Tailored Resume

Cover Letter