U.S. Regulatory Strategy - Obesity and Related Conditions, Senior Manager

Senior Manager, U.S. Regulatory Strategy – Obesity and Related Conditions In this vital role you will support products in the Obesity and Related Conditions therapeutic area. As the U.S. regulatory lead for global programs, you will develop and execute regulatory strategy in close partnership with the Global Regulatory Lead and key market leads, represent the U.S. on global teams, and contribute to global regulatory and clinical development strategies. Your responsibilities include translating scientific and clinical insights into actionable regulatory strategies, managing U.S. regulatory submissions, leading labeling strategy, engaging Health Authority interactions, assessing regulatory risk, and ensuring ongoing compliance for assigned products. Responsibilities Contribute to 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, 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, including clinical trial and marketing applications, in alignment with global filing plans and regulatory requirements. Lead development of key regulatory documents such as 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, including expedited programs, orphan designation, and pediatric strategy. 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 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 directly related experience Master’s degree and 6 years of directly related experience Bachelor’s degree and 8 years of directly related experience Associate’s degree and 10 years of directly related experience High school diploma / GED and 12 years of directly related experience Minimum of 2 years experience directly managing people and/or leading teams, projects, programs, or directing the allocation of resources. 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. 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. Experience working with policies, procedures, and SOPs in a regulated environment. Benefits Competitive salary within the range of $149,396.85 to $202,125.15, based on experience and qualification. Health and welfare plans for staff and eligible dependents. Retirement and savings plan with generous company contributions. Group medical, dental, and vision coverage. Life and disability insurance. Flexible spending accounts. Discretionary annual bonus program and stock‑based long‑term incentives. Generous time‑off plans and flexible work models where possible. Professional development and career growth opportunities. Equal Opportunity Employment Amgen is an Equal Opportunity Employer and encourages diverse and qualified applicants to apply. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected characteristic. We provide reasonable accommodations for qualified individuals with disabilities. #J-18808-Ljbffr Amgen Inc. (IR)