Kai Cheng Tsai
About Kai Cheng Tsai
Kai Cheng Tsai is a Senior Manager, Regulatory CMC Cell Therapy at Bristol Myers Squibb with extensive experience in CAR-T cell therapy and regulatory affairs.
Current Title and Role
Kai Cheng Tsai currently serves as the Senior Manager, Regulatory CMC Cell Therapy at Bristol Myers Squibb. He is based in Princeton, New Jersey, and provides regulatory leadership in cell therapy.
Previous Experience at Legend Biotech
Before joining Bristol Myers Squibb, Kai Cheng Tsai worked at Legend Biotech, holding roles as a Supervisor and Senior Associate of Regulatory CMC (CAR-T Cell Therapy) in Piscataway, New Jersey. During his four-year tenure from 2018 to 2022, he focused on regulatory affairs associated with CAR-T cell therapy.
Educational Background
Kai Cheng Tsai holds multiple advanced degrees. He earned a Master of Science in Analytics from Harrisburg University of Science and Technology (2019-2021). Additionally, he obtained a Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University (2016-2018). He also holds a Master of Science in Biopharmaceutical Science from National Yang Ming University (2009-2011) and a Bachelor of Science in Life Science from National Central University (2005-2009).
Experience in Regulatory Affairs and Compliance
Kai Cheng Tsai has a comprehensive background in regulatory affairs and compliance. He worked as a Regulatory Project Manager at the Division of Regulatory Affairs and Compliance, Center for Drug Evaluation, Taiwan, from 2014 to 2016. Prior to that, he served as a Deputy Engineer for GMP Compliance/Analytical Validation at China Chemical & Pharmaceutical from 2012 to 2014.
Professional Achievements
Kai Cheng Tsai has participated in four cGMP sponsor audits in Japan and Taiwan, managed over 300 applicant submissions in IND, NDA, BLA, and BSE applications, and participated in an FDA pre-approval inspection at manufacturing plants. His global regulatory CMC experience stretches over four years, with specific expertise in CAR-T cell therapy and project management in IND/NDA/BLA at a regulatory agency for over two years.