Director, Global Regulatory Affairs – Cardiometabolic Disorders

Amgen • Thousand Oaks, CA

5d

About The Position

The Global Regulatory Affairs Director provides strategic regulatory leadership for programs focused on obesity and related cardiometabolic conditions. The role develops and executes global regulatory strategies, shapes cross-functional decisions, and leads interactions with health authorities and external partners. It integrates scientific, clinical, nonclinical, CMC, and safety evidence while accounting for the complexities of metabolic disorders and relevant regulatory precedent.

The Director leads global regulatory teams, oversees major submissions and regulatory documentation, and guides teams on evolving FDA and EMA guidance. The role also represents Amgen in external alliances and policy discussions and builds, mentors, and supports high-performing global regulatory teams.

Requirements

• Doctorate degree and 4 years of regulatory experience, or a master’s degree and 7 years of regulatory experience, or a bachelor’s degree and 9 years of regulatory experience.
• Strong scientific literacy in metabolism, energy-balance physiology, hormone-signaling pathways, adiposity biology, and associated clinical endpoints.
• Experience developing global submissions and leading interactions with FDA, EMA, and other regulatory bodies.
• Demonstrated success leading Global Regulatory Teams and influencing governance bodies on complex regulatory and clinical development issues.
• Ability to translate metabolic science into clear regulatory strategy and decision-making frameworks.
• Strong communication and negotiation skills, including the ability to guide teams through ambiguous or high-stakes situations.

Nice To Haves

• 8–10+ years of global regulatory experience, with demonstrated leadership of regulatory strategy for programs in obesity, metabolic disorders, endocrinology, cardiovascular risk, or related therapeutic areas.
• Experience in real-world evidence strategy, long-term outcome measures, and chronic disease regulatory considerations.

Responsibilities

• Develop and lead global regulatory strategies for obesity and metabolic disease programs.
• Integrate clinical, nonclinical, CMC, and safety evidence into regulatory recommendations, accounting for relevant regulatory precedent.
• Lead the Global Regulatory Strategic Plan, including risk assessment, scenario planning, and evaluation of novel or expedited pathways.
• Advise on clinical development elements such as study design, chronic-treatment safety, cardiovascular outcomes evaluation, metabolic biomarkers, pediatric development, and real-world evidence plans.
• Lead the Global Regulatory Team and represent Global Regulatory Affairs and Strategy on cross-functional teams.
• Partner with Clinical Development, Safety, CMC, Value & Access, Commercial, and regional regulatory colleagues to execute strategies.
• Translate metabolic science into actionable regulatory strategy and facilitate alignment on risk–benefit considerations and long-term labeling strategy.
• Oversee global regulatory submissions, including clinical trial applications, marketing applications, pediatric plans, and labeling updates.
• Ensure consistency, scientific rigor, and clarity across core regulatory documents, including TPL, CDS, and briefing materials.
• Guide regulatory interpretation of evolving FDA and EMA guidance related to obesity and related conditions, where applicable.
• Lead strategy development and cross-functional preparation for health authority interactions, including discussions of protocol advice, cardiovascular safety, efficacy endpoints, long-term safety monitoring, pediatrics, and labeling.
• Represent Amgen in external alliances, consortia, scientific policy discussions, and trade associations focused on obesity, metabolic disease, or cardiometabolic health.
• Anticipate health authority perspectives 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 in metabolic disease science, regulatory strategy, and global execution.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.
• Group medical, dental, and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.
• Career development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Director