Regulatory Affairs, Sr Manager – Obesity And Related Conditions

Amgen Inc

United States
Base: $153,935.00 - $184,298.00 usd annually; bonu...
U.s. regulatory submissions experience
Fda interaction and health authority engagement
Obesity and metabolic disease therapeutic knowledge
This role serves as the U.S. Regulatory Lead for global programs in obesity and related cardiometabolic conditions, ensuring compliance with FDA requirements

Job Summary

  • This role serves as the U.S. Regulatory Lead for global programs in obesity and related cardiometabolic conditions, ensuring compliance with FDA requirements.
  • The successful candidate will develop and execute regulatory strategies, lead U.S. labeling efforts, and manage interactions with health authorities to secure commercial licenses.
  • Amgen offers a comprehensive benefits package including retirement plans, health coverage, stock incentives, and flexible work models to support professional growth.

Matching Summary

This role serves as the U.S. Regulatory Lead for global programs in obesity and related cardiometabolic conditions, ensuring compliance with FDA requirements.

Salary

Base: $153,935.00 - $184,298.00 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

  • U.S. regulatory submissions experience
  • FDA interaction and Health Authority engagement
  • Obesity and metabolic disease therapeutic knowledge

Nice-to-have

  • Global regulatory team collaboration
  • Cross-functional leadership skills
  • Labeling strategy negotiation experience

Key Requirements

  • Doctorate degree plus 2 years regulatory experience OR Master's plus 4 years OR Bachelor's plus 6 years
  • Demonstrated experience with U.S. regulatory submissions and direct FDA interaction
  • Experience contributing to regulatory strategy and risk assessment in partnership with global leadership

Work Rights

Not specified

Tailored Resume

Cover Letter