Director, Global Regulatory Affairs – Cardiometabolic Disorders

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Career Category Regulatory Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Director, Global Regulatory Affairs – Cardiometabolic Disorders What you will do Let’s do this. Let’s change the world. The Global Regulatory Affairs Director provides strategic regulatory leadership for programs focused on obesity and related cardiometabolic conditions—a rapidly evolving therapeutic area requiring sophisticated scientific, clinical, and regulatory assessment. You will be accountable for developing and executing global regulatory strategies, shaping cross-functional decision-making, and leading global interactions with Health Authorities and external partners. This role ensures regulatory strategies fully reflect the unique scientific, mechanistic, and clinical complexities of metabolic disorders. Key Responsibilities Regulatory Strategy & Scientific Leadership Develop and lead global regulatory strategy for obesity and metabolic disease programs, grounded in a strong understanding of metabolic biology, endocrine pathways, adiposity-related physiology, and cardiometabolic risk science. Integrate clinical, nonclinical, CMC, and safety evidence into cohesive regulatory recommendations, accounting for regulatory precedent in obesity and related conditions. Lead the creation of the Global Regulatory Strategic Plan (GRSP), including risk assessment, regulatory scenario planning, and evaluation of novel/expedited pathways. Advises on key clinical development elements relevant to obesity programs—study designs, chronic treatment safety, cardiovascular outcomes evaluation, metabolic biomarker selection, pediatric development, and real-world evidence plans. Cross-Functional Influence & Enterprise Collaboration Lead the Global Regulatory Team (GRT) and represent Global Regulatory Affairs and Strategy (GRAAS) on cross-functional teams (e.g. Indication Team, Evidence Generation Team, Global Safety Team etc.). Partner closely with Clinical Development, Safety, CMC, Value & Access, Commercial, and regional regulatory colleagues to ensure seamless strategy execution. Translate complex metabolic science into actionable regulatory strategy for cross-functional partners, facilitating alignment on risk–benefit thinking and long-term labeling strategy. Regulatory Execution & Documentation Excellence Oversee execution of major global regulatory submissions, including clinical trial applications, initial and supplemental marketing applications, pediatric plans, and labeling updates relevant to obesity programs. Ensure consistency, scientific rigor, and clarity across core regulatory documents—especially TPL, CDS, and briefing materials. Guides the regulatory interpretation of evolving FDA/EMA guidance related to obesity and related conditions (where applicable). HA & External Stakeholder Engagement Lead strategy development, preparation, and cross-functional alignment for key Health Authority interactions (FDA, EMA, PMDA, NMPA, etc.) related to obesity and other cardiometabolic indications, including protocol advice, CV safety considerations, efficacy endpoints, long-ter

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