Director, Global Regulatory Lead Obesity & Related ; Chronic Weight

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Lets do this. Lets change the world. The Director, Global Regulatory Lead (GRL) provides strategic regulatory leadership for programs focused on obesity and related cardiometabolic conditionsa 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.

• 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.

• 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.

• 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).

• Lead strategy development, preparation, and…