As a Director, Global Regulatory Lead, you will provide strategic regulatory leadership for programs focused on obesity and related cardiometabolic conditions. You will develop and execute global regulatory strategies, shape cross-functional decision-making, and lead global interactions with Health Authorities and external partners.
Requirements
- Doctorate degree and 4 years of regulatory experience
- Master’s degree and 7 years of regulatory experience
- 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
- Comprehensive employee benefits package
- Discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models