• 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