Director, Global Regulatory Affairs – Cardiometabolic Disorders

Amgen•Thousand Oaks, CA

7d•$195,640 - $264,690

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 decision-making, and leads interactions with Health Authorities and external partners. It ensures regulatory strategies account for the scientific, mechanistic, and clinical complexities of metabolic disorders. The Director integrates clinical, nonclinical, CMC, and safety evidence into regulatory recommendations; leads the Global Regulatory Team; oversees global submissions and regulatory documentation; and guides teams through Health Authority discussions and evolving regulatory guidance. The role also represents Amgen in external alliances and policy discussions and builds, mentors, and develops 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.

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.
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.
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, informed by metabolic biology, endocrine pathways, adiposity-related physiology, and cardiometabolic risk science.
Integrate clinical, nonclinical, CMC, and safety evidence into regulatory recommendations, taking relevant regulatory precedent into account.
Lead creation of the Global Regulatory Strategic Plan, including risk assessment, regulatory scenario planning, and evaluation of novel or expedited pathways.
Advise on clinical development elements, including study designs, 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 strategy.
Translate metabolic science into actionable regulatory strategy and facilitate cross-functional alignment on risk–benefit considerations and long-term labeling strategy.
Oversee global regulatory submissions, including clinical trial applications, initial and supplemental 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.
Develop strategies and prepare cross-functional teams for Health Authority interactions with agencies such as FDA, EMA, PMDA, and NMPA.
Represent Amgen in external alliances, consortia, scientific policy discussions, and trade associations focused on obesity, metabolic disease, or cardiometabolic health.
Anticipate Health Authority perspectives based on obesity-related precedent 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

Health and welfare plans for staff and eligible dependents.
Financial plans with opportunities to save for retirement or other goals.
Work/life balance and career development opportunities.
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.