Regulatory Affairs, Sr Manager – Obesity and Related Conditions

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 Senior Manager– 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 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. You will represent the U.S. on global teams, contribute to global regulatory and clinical development strategies, and support the acquisition and maintenance of commercial licenses.

This role requires the ability to translate scientific and clinical insights into clear, actionable regulatory strategies.

Purpose: Ensure Amgen secures and maintains required U.S. licenses and authorizations to support clinical development and marketed products in compliance with regulatory requirements.

People Leadership: Provides matrix and peer leadership and may directly manage regulatory leads and/or support staff, depending on level.

Reporting Line: Reports to a GRL; with primary interaction within 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

• Contribute to the development and refinement of global regulatory strategy in partnership with the GRL, providing U.S.-specific insights on regulatory precedent, risk, and Health Authority expectations in obesity and related metabolic conditions.
• Apply scientific expertise in obesity and metabolic disease to inform regulatory strategy, including clinical endpoints and long-term safety considerations.
• Partner with the GRL and key market leads to align on global development timelines, core documents (e.g., protocols, IBs, KDEs), and regulatory positioning.
• Execute the U.S. regulatory strategy for assigned programs and represent the region on global governance teams.
• Plan and lead U.S. regulatory submissions (e.g., clinical trial and marketing applications) in alignment with global filing plans and regulatory requirements.
• Lead development of key regulatory documents, including labels, briefing packages, and submission components aligned with product strategy.
• Drive U.S. labeling strategy and execution in collaboration with the Labeling Working Group, including negotiation approach, timelines, and deviation/waiver decisions.
• Provide strategic input on U.S. development pathways (e.g., expedited programs, orphan designation, pediatric strategy), informed by the evolving regulatory landscape.
• Lead Health Authority interactions for assigned products, including preparing and leading engagements and communicating outcomes to the GRT and senior management.
• Manage responses to agency questions (RTQs) and feedback by coordinating cross-functional input and ensuring timely, high-quality submissions.
• Assess regulatory risk and likelihood of success; communicate scenarios and contingencies to the GRL, GRT, and senior management.
• Ensure ongoing compliance for assigned products (e.g., commitments, obligations, regulatory records) and proactively escalate issues.
• Monitor and apply U.S. regulatory intelligence, including evolving legislation, guidance, and relevant competitor activity.
• Partner with cross-functional teams (Clinical, Medical, Safety, Commercial) to ensure aligned strategy and support U.S. data and promotional considerations.
• Lead and develop staff, where applicable, through prioritization, coaching, and resource planning to deliver on program objectives.

Basic Qualifications:

Doctorate degree and 2 years of regulatory experience
OR
Master’s degree and 4 years of regulatory experience
OR
Bachelor’s degree and 6 years of regulatory experience
OR
Associate’s degree and 10 years of regulatory experience
OR

High school diploma / GED and 12 years of regulatory experience

• Demonstrated experience with U.S. regulatory submissions and direct FDA interaction, with strong knowledge of the U.S. regulatory environment and drug development lifecycle.
• Experience contributing to regulatory strategy, including risk assessment, scenario planning, and Health Authority engagement in partnership with global leadership.

Preferred Qualifications:

• Experience supporting or leading regulatory strategy for programs in obesity, metabolic disorders, endocrinology, or related therapeutic areas.
• Strong scientific literacy in obesity and metabolic disease, including metabolic pathways, weight regulation biology, and relevant clinical endpoints (e.g., weight loss, cardiovascular outcomes, metabolic biomarkers).
• Experience leading U.S. labeling strategy, including negotiation and timeline management in a cross-functional environment.
• Strong communication and influencing skills, with the ability to drive alignment and resolve conflicts.
• Experience supporting regulatory submissions or Health Authority interactions outside the U.S. in collaboration with global teams is a plus.

Experience working with policies, procedures, and SOPs in a regulated environment