Director, Global Regulatory Lead - Obesity & Related Conditions (Chronic Weight

Position: Director, Global Regulatory Lead - Obesity & Related Conditions (Chronic Weight)
** 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 Lead - Obesity & Related Conditions (Chronic Weight)*
* ** What you will do*
* Let'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 Responsibilities*
* ** Regulatory Strategy & Scientific Leadership*
* + Develop and lead global regulatory strategy for obesity and metabolic disease programs, with specific focus on Chronic Weight, 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 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…