Regulatory Affairs, Sr Manager - Obesity and Related Conditions

United States Regulatory Senior Manager – Obesity and Related Conditions 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. What you will do 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. 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). 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 elevate 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
• Master’s degree and 4 years of regulatory experience
• Bachelor’s degree and 6 years of regulatory experience
• Associate’s degree and 10 years of regulatory experience
• 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 Benefits As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities. A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan. Stock‑based long‑term incentives. Award‑winning time‑off plans. Flexible work models where possible. Equal Opportunity Employment Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #J-18808-Ljbffr Amgen SA