Global Regulatory Director Lead – Obesity & Related Conditions (Type II Diabetes

Career CategoryRegulatoryJob DescriptionJoin Amgen’s Mission of Serving PatientsAt 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 Lead – Obesity & Related ConditionsWhat you will doLet’s do this. Let’s change the world. The Director, Global Regulatory Lead (GRL) 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. The GRL is 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 ResponsibilitiesRegulatory Strategy & Scientific LeadershipDevelop and lead global regulatory strategy for obesity and metabolic disease programs with focus on Type II diabetes, 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 CollaborationLead 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 ExcellenceOversee 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 EngagementLead strategy development, preparation, and cross-functional alignment for key Health Authority interactions (FDA, EMA, PMDA, NMPA, etc.) related to metabolic disorders, including protocol advice, CV safety considerations, efficacy endpoints, long-term safety monitoring, and pediatric/labeling discussions.Represent Amgen in external alliances, consortia, scientific policy discussions, and trade associations focused on obesity, metabolic disease, or cardiometabolic health.Anticipate HA perspectives informed by precedent in the obesity space (e.g., benefit–risk expectations, CV outcomes requirements, weight-loss durability concerns) and prepare teams for high-stakes discussions.People Leadership, Team Performance & Cultural AgilityBuild, mentor, and support high-performing global regulatory teams.Foster an inclusive, collaborative environment that encourages diverse perspectives, scientific rigor, and healthy debate.Develop regulatory talent with expertise in metabolic disease science, regulatory strategy, and global execution.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a [type of person] with these qualifications.Basic Qualifications:Doctorate degree and 4