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

Location: Washington, D.C., United States

Company

hirify.global is a biotechnology company developing and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Develop and lead global regulatory strategies for obesity, Type II diabetes, and related cardiometabolic disease programs.
• Integrate clinical, nonclinical, CMC, and safety evidence into regulatory recommendations and strategic plans.
• Lead the Global Regulatory Team and collaborate with Clinical Development, Safety, CMC, Value & Access, Commercial, and regional regulatory functions.
• Oversee global regulatory submissions, pediatric plans, labeling updates, and core regulatory documentation.
• Lead preparation for Health Authority interactions with FDA, EMA, PMDA, NMPA, and other agencies.
• Build, mentor, and support high-performing regulatory teams while fostering scientific rigor and collaboration.

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.
• Expertise in global regulatory strategy and regulatory execution for complex clinical development programs.
• Understanding of metabolic biology, endocrine pathways, adiposity-related physiology, and cardiometabolic risk science.
• Experience with clinical development topics including chronic treatment safety, cardiovascular outcomes, metabolic biomarkers, pediatric development, and real-world evidence.
• Experience preparing for and leading interactions with global Health Authorities.

Culture & Benefits

• Comprehensive medical, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Award-winning time-off plans and flexible work models where applicable.
• Inclusive, collaborative, science-based work environment focused on serving patients.