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

Lifelancer
Washington, DC
Category Operations
Job Description
Join Amgen's Mission of Serving Patients. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. The Global Regulatory Director Lead – Obesity & Related Conditions is responsible for providing strategic regulatory leadership for programs focused on obesity and related cardiometabolic conditions.

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, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • Discretionary annual bonus program
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible
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