tony-yang

Tony Yang

Part-time lecturer, MS in Biomedical Regulatory Affairs (BRAMS) Program

Pharmacy Faculty, School Faculty

 

 

Biography

Tony Yang is a part-time lecturer in the University of Washington (UW) Department of Pharmacy and contributes to the UW BRAMS Practicum Program. He began his career in biopharmaceutical sector, specializing in quality assurance (QA). In this role, he supported quality management systems (QMS) and led cleanroom environmental monitoring initiatives. Tony later transitioned to the in vitro diagnostics (IVD) sector, where he continued advancing QMS practices and managed regulatory submissions, including 510(k) clearances and EU Technical Files. His expertise expanded into regulatory affairs (RA), guiding medical device compliance during the COVID-19 enforcement policy period. Currently, Tony serves as a Senior Regulatory Coordinator at Fred Hutchinson Cancer Center in Seattle, focusing on Research IND management and providing regulatory guidance to physicians and study teams. Yang is a graduate of the UW BRAMS program.