Regulatory Affairs VP

Summary

This position is responsible for leading Gan & Lee Pharmaceuticals’ regulatory affairs activities in the U.S. and European markets. This role oversees strategy development, submissions, and compliance with FDA, EMA, and other key authorities, ensuring timely approval of innovative medicines. The VP will manage the regulatory team, budgets, and operational processes, while fostering cross-regional collaboration to support the company’s global expansion, particularly in metabolic disease areas.

Education and Credentials

• Advanced degree (Master’s or above; PhD preferred) in Pharmacy, Medicine, Biology, Chemistry, or related fields
• Professional certifications in regulatory affairs (e.g., RAC) are preferred

Experience

• Minimum 15 years’ experience in regulatory affairs, including at least 10 years directly engaging with FDA/EMA
• Proven senior leadership experience in multinational pharma/biotec...