United States Regulatory Lead – Obesity and Related Conditions TA

Role Summary

United States Regulatory Lead for Obesity and Related Conditions, a product-facing role within Global Regulatory Affairs that develops and executes U.S./regional regulatory strategy to enable clinical trials and maintain commercial licenses, with a strong focus on regulatory compliance and patient safety. The role reports to a Global Regulatory Lead, is based in the assigned region, and interacts primarily with the Global Regulatory Team.

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 GRT and senior management.
• Manage Responses to Questions (RTQs) and other agency feedback by coordinating cross-functional inputs, driving alignment, and ensuring timely, high-quality responses.
• Assess regulatory risk and likelihood of success; communicate scenarios, expectations, and contingencies to GRT and line management.
• Ensure ongoing regulatory compliance for assigned products (e.g., commitments, obligations, regulatory history/record accuracy) and escalate issues proactively.
• Maintain and apply U.S. regulatory intelligence: monitor evolving legislation/guidance and assess/communicate impact (including competitor labeling where relevant).
• Partner with cross-functional teams (Clinical, Medical, Safety, Commercial) to ensure strategy alignment, including support for U.S. promotional/data applicability considerations as needed.
• If applicable, lead and develop staff through clear prioritization, coaching, and resource planning to meet program objectives.

Qualifications

• Required: Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and 8 years of directly related experience OR Associate’s degree and 10 years of directly related experience.
• Preferred: Regulatory submissions experience and demonstrated experience interacting with regulatory agencies (FDA).
• Preferred: Strong knowledge of the U.S. regulatory environment and drug development lifecycle.
• Preferred: Experience developing/implementing regulatory strategy, including risk management and contingency planning.
• Preferred: Experience leading U.S. labeling strategy, negotiation, and timeline management in a cross-functional setting.
• Preferred: Strong communication and influencing skills; ability to drive alignment and resolve conflicts.
• Preferred: Experience working with policies, procedures, and SOPs in a regulated environment.
• Preferred: Experience supporting programs in Obesity, Diabetes, or related metabolic diseases.