Global Regulatory Affairs Director, Obesity and Related

Global Regulatory Lead - Obesity and Related Conditions

Amgen is seeking a Global Regulatory Director to provide 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 Global Regulatory Lead 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.

We’re looking for a visionary leader ready to drive our regulatory strategy and execution for obesity and related cardiovascular conditions.

• Develop and lead the 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.
• Advise 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 and represent GRAAS on cross‑functional teams (e.g., Indication Team, Evidence Generation Team, Global Safety Team).
• 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.
• Guide the regulatory interpretation of evolving FDA/EMA guidance related to obesity and related conditions (where applicable).

• 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 discussions, and trade associations focused on obesity, metabolic disease, or cardiometabolic health.
• Anticipate Health Authority 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.

• Build, 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.

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

• Doctorate degree and 5 years of regulatory experience in biotech or science.
• Masters degree and 8 years of regulatory experience in biotech or science.
• Bachelor’s…