Hee NamGung

Hee is a licensed pharmacist in Korea with a bachelor’s and master’s degrees in Pharmacy, and over 15 years of experience in clinical research and regulatory affairs. She has worked in clinical development at a Korean pharmaceutical company and in global regulatory affairs at a global CRO, where she supported regulatory submissions across multiple regions, including EMEA and APAC.

She later joined the Ministry of Food and Drug Safety (MFDS) in Korea, where she conducted regulatory inspections of clinical trials and contributed to the development of national guidelines. She also handled a wide range of inquiries from industry and clinical research professionals through Korea’s official public communication platform, providing regulatory interpretations and practical guidance across all aspects of clinical trial operations.

As a Scientific and Regulatory Senior Consultant, she offers strategic regulatory guidance to support efficient and innovative clinical trial strategies. With experience in both industry and government, she brings a balanced and collaborative approach to every project.