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, manage key submissions, and lead Health Authority interactions to secure commercial licenses.
Amgen offers a competitive salary range of $153,935.00 to $184,298.00 USD along with comprehensive benefits including retirement plans and stock-based incentives.
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; Bonus/Equity: Discretionary annual bonus and stock-based long-term incentives; Benefits: Comprehensive health, dental, vision, retirement plan, and flexible work models
Skills & Requirements
Must-have
U.S. regulatory submissions experience
FDA interaction and engagement
Global regulatory strategy development
Obesity and metabolic disease knowledge
Labeling strategy leadership
Nice-to-have
Cross-functional team collaboration skills
Expedited program pathway experience
Strong scientific literacy in weight regulation
Influencing and conflict resolution abilities
International regulatory submission experience
Key Requirements
Doctorate degree plus 2 years regulatory experience
Master's degree plus 4 years regulatory experience
Bachelor's degree plus 6 years regulatory experience
Demonstrated FDA interaction and U.S. submission experience
Experience in obesity or metabolic disorder therapeutic areas