United States Regulatory Sr Manager – Obesity and Related Conditions TA

Role Summary

United States Regulatory Sr Manager – Obesity and Related Conditions TA. Develops and executes U.S./regional regulatory strategy for Obesity and Related Conditions products, leads regulatory submissions, manages Health Authority interactions, and ensures regulatory compliance to support clinical trials and marketed products, with emphasis on patient safety. Provides leadership to regulatory staff where applicable.

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
• Required: Master’s degree and 6 years of directly related experience
• Required: Bachelor’s degree and 8 years of directly related experience
• Required: 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