Role OverviewAmgen is seeking a United States Regulatory Lead (USRL) supporting products in the Obesity and Related Conditions Therapeutic Area. The role will develop and execute regulatory strategy in close partnership with the Global Regulatory Lead (GRL), serving as the U.S. regulatory lead for global programs in obesity and related cardiometabolic conditions.
What You Will Do
Develop and execute regulatory strategy, contribute to global regulatory and clinical development strategies, and support the acquisition and maintenance of commercial licenses. Represent the U.S. on global teams and lead Health Authority interactions for assigned products.
Why It Might Be a Fit
The role requires the ability to translate scientific and clinical insights into clear, actionable regulatory strategies. The ideal candidate will have experience with U.S. regulatory submissions and direct FDA interaction, with strong knowledge of the U.S. regulatory environment and drug development lifecycle.
Requirements
- Doctorate degree and 2 years of regulatory experience
- Master’s degree and 4 years of regulatory experience
- Bachelor’s degree and 6 years of regulatory experience
- Associate’s degree and 10 years of regulatory experience
- High school diploma / GED and 12 years of regulatory experience
Benefits
- Comprehensive employee benefits package
- Discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models
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