Global Regulatory Director Lead – Obesity & Related Conditions (Type II Diabetes)

Director, Global Regulatory Lead – Obesity & Related Conditions

Responsibilities
- Develop and lead global regulatory strategy for obesity and metabolic disease programs focused on Type II diabetes.
- Integrate clinical, nonclinical, CMC, and safety evidence into cohesive regulatory recommendations.
- Lead creation of the Global Regulatory Strategic Plan (GRSP), including risk assessment and regulatory scenario planning, and evaluation of novel/expedited pathways.
- Advise on key clinical development elements: 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.
- Partner with Clinical Development, Safety, CMC, Value & Access, Commercial, and regional regulatory colleagues to execute strategy.
- Oversee major global regulatory submissions (clinical trial applications, initial and supplemental marketing applications, pediatric plans, and labeling updates).
- Ensure consistency, scientific rigor, and clarity across core regulatory documents (especially TPL, CDS, and briefing materials).
- Guide interpretation of evolving FDA/EMA guidance related to obesity and related conditions.
- Lead Health Authority interaction strategy and cross-functional alignment (FDA, EMA, PMDA, NMPA, etc.), including protocol advice, CV safety, efficacy endpoints, long-term safety monitoring, and pediatric/labeling discussions.
- Represent Amgen in external alliances, consortia, scientific policy discussions, and trade associations.
- Build, mentor, and support global regulatory teams; foster inclusive collaboration and develop regulatory talent.

Qualifications
- 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

Preferred
- 8–10+ years of global regulatory experience with demonstrated leadership in Type II diabetes/obesity/metabolic disorders, endocrinology, cardiovascular risk, or related areas.
- Strong scientific literacy in metabolism, energy balance physiology, hormone signaling pathways, adiposity biology, and related clinical endpoints.
- Experience developing global submissions and leading interactions with FDA, EMA, and other regulatory bodies.
- Demonstrated success leading GRTs and influencing governance bodies.
- Proven ability to translate metabolic science into regulatory strategy and decision-making frameworks.
- Strong communication and negotiation skills for ambiguous/high-stakes situations.
- Plus: real-world evidence strategy, long-term outcome measures, and chronic disease regulatory considerations.

Application Instructions
- Apply now via careers.amgen.com; there is no application deadline and applications will be accepted until a sufficient number is received or a candidate is selected.
- Sponsorship for this role is not guaranteed.