United States Regulatory Lead – Obesity and Related Conditions TA

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION? 

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.  

OR 

United States Regulatory Lead– Obesity and Related Conditions  

Live 

What you will do 

Let’s do this! Let’s change the world!  

Amgen is seeking a United States Regulatory Lead (USRL) supporting products in the Obesity and Related Conditions Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of all Amgen molecules. 

In this product-facing role, you will develop and execute U.S./regional regulatory strategy and tactics under general supervision, represent the region on global teams, and lead U.S. regulatory execution to enable clinical trials and maintain commercial licenses in compliance with local laws, regulations, and Amgen standards—with a strong focus on regulatory compliance and patient safety. 

Purpose: Ensure Amgen acquires and maintains required U.S. licenses/authorizations to support clinical trials and maintain marketed products, while ensuring regulatory compliance with a focus on patient safety. 

People leadership: This role provides matrix/peer leadership and may directly manage one or more regulatory leads and/or support staff (dependent on grade). 

Reporting line: Reports to a Global Regultory Lead (GRL); based in the assigned region with interaction primarily on the Global Regulatory Team (GRT). 

Win 

What we expect of you 

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.  

Key responsibilities 

• Execute the approved U.S. regulatory strategy for assigned programs and represent the region on global governance teams (e.g., GRT; may include GDT/CST/LWG as applicable). 

• Plan and lead U.S. regulatory submissions (e.g., clinical trial and marketing applications) in alignment with global filing plans, U.S. regulatory requirements, and Amgen standards. 

• Lead U.S. regulatory document development, including labels, briefing packages, and key submission components consistent with product strategy. 

• Drive U.S. labeling strategy and execution in collaboration with the Labeling Working Group (LWG), including negotiation approach, timelines, and deviation/waiver decisions as applicable. 

• Provide regulatory direction on U.S. mechanisms and pathways to optimize development (e.g., expedited programs, orphan considerations, pediatric plans, compassionate use where applicable). 

• Lead Health Authority interactions for assigned products: build relationships, prepare/lead engagements, and document/communicate outcomes to