Global Regulatory Affairs Director

Job Summary

Leading global regulatory strategy for obesity and cardiometabolic disorders, the full-time remote Global Regulatory Affairs Director will develop regulatory plans, oversee major submissions, and engage with health authorities while fostering cross-functional collaboration.

Key Responsibilities

• Develop and lead global regulatory strategy for obesity and metabolic disease programs
• Oversee execution of major global regulatory submissions and ensure scientific rigor across regulatory documents
• Lead strategy development for key Health Authority interactions and represent the organization in external alliances

Required Qualifications

• Doctorate degree and 4 years of regulatory experience, or Master's degree and 7 years, or Bachelor's degree and 9 years of regulatory experience
• 8-10+ years of global regulatory experience with leadership in obesity or metabolic disorders
• Strong scientific literacy in metabolism and related clinical endpoints
• Experience developing global submissions and leading interactions with regulatory bodies like FDA and EMA
• Proven ability to translate complex metabolic science into regulatory strategies