Dong Yang, PhD, DABT, RAC
Executive Director, Regulatory Affairs & Head of Regulatory Affairs, China
Dong Yang is Head of Regulatory Affairs at Fortrea China with more than 20 years of experience in drug development and regulatory affairs, supporting IND-, NDA-, and BLA-enabling programs. A board-certified Regulatory Affairs Professional (RAC Global), he leads regulatory strategy and execution, providing scientific review, gap analysis of submission dossiers, and guidance on clinical development planning in collaboration with clients and regulatory agencies.
Dong has led more than 50 regulatory agency interactions, consultation meetings, and key opinion leader engagements across multiple therapeutic areas. His experience includes IND and NDA/BLA submissions, HGRAC filings, and CIQ applications. In addition, he leads Fortrea’s regulatory contributions to the NMPA 14th Five-Year Regulation and Guideline Update and Maintenance Program, supporting evolving regulatory frameworks in China.