Global Regulatory Director Lead – Obesity & Related Conditions, Type II Diabetes
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Job Description
Director providing regulatory leadership for obesity and related conditions at Amgen. Developing global strategies and leading interactions with health authorities.
Responsibilities:
- The Director, Global Regulatory Lead (GRL) provides strategic regulatory leadership for programs focused on obesity and related cardiometabolic conditions.
- 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.
- Develop and lead global regulatory strategy for obesity and metabolic disease programs with focus on Type II diabetes.
- Integrate clinical, nonclinical, CMC, and safety evidence into cohesive regulatory recommendations.
- Lead the creation of the Global Regulatory Strategic Plan (GRSP), including risk assessment and regulatory scenario planning.
- Advise on key clinical development elements relevant to obesity programs.
- Lead the Global Regulatory Team (GRT) and represent Global Regulatory Affairs and Strategy (GRAAS) on cross-functional teams.
- Oversee execution of major global regulatory submissions, including clinical trial applications and marketing applications.
- Lead strategy development and preparation for key Health Authority interactions related to metabolic disorders.
- Build, mentor, and support high-performing global regulatory teams.
Requirements:
- Doctorate degree and 4 years of regulatory experience OR Master’s degree and 7 years of regulatory experience OR Bachelor’s degree and 9 years of regulatory experience
- 8–10+ years of global regulatory experience, with demonstrated leadership of regulatory strategy for programs in Type II diabetes, 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 GRTs and influencing governance bodies on complex regulatory and clinical development issues.
- Proven ability to translate metabolic science into clear regulatory strategy and decision-making frameworks.
- Strong communication and negotiation skills, with 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 is a plus.
Benefits:
- A 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
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible.
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