John Choi

John Choi is a seasoned regulatory affair professional with more than 18 years of experience in drug development and global/US regulatory affairs at various biotech companies. He has developed regulatory strategies and led the submissions activities throughout the product lifecycle, including early discovery to marketing application approval and commercialization. He has hands-on experience in cell therapy, gene therapy, and other novel modalities, as well as in rare and complex diseases. John joins Ambys from Platelet BioGenesis, where he led the regulatory affairs function and spearheaded the pre-IND and IND activities for the company’s novel allogeneic cell therapy program. Previously, he was Senior Director of Regulatory Affairs Strategy at Rubius, where he supported the company’s pre-IND and IND submissions for their early-stage oncology programs. John also held regulatory affairs leadership roles at ImmunoGen, Mallinckrodt Pharmaceuticals, Questcor Pharmaceuticals, Intercell, and ICON Clinical Research.

John earned his M.S. in biotechnology and B.A. in biology from Johns Hopkins University and holds a Regulatory Affairs Certification from the Regulatory Affairs Professionals Society.