Jason She

Jason has over 10 years’ experience in IND and NDA submissions of different types of products to FDA and NMPA, including Novel Biologics, Biosimilars, and Cell & Gene Therapy applications. Jason provides strategic guidance to clients on the drug development and regulatory submission, and coordinates with other disciplines in providing drug product development strategies with the goal of anticipating regulatory challenges and leveraging Parexel’s multidisciplinary expertise.

Work experience

Before joining Parexel, Jason was a Regulatory Affairs and Strategic Director in a top start-up company in China focusing on first-in-class oncology products and diabetes products. He successfully empowered the regulatory team and brought several IND approvals in both the US and China. He is proficient in the drug regulatory aspects, technical understanding, and drug review evaluation of new drug products pertaining to Pre-INDs, INDs and NDAs. He also was adjunct director of “Centre of Stem Cell Research and Translational Medicine” in Fujian Academy of Medicine in China. He published more than twenty first-author or co-authored conference abstracts and manuscripts in peer-reviewed international medical journals.

Education

Jason received his Ph.D. in Physiology (blood coagulation and inflammatory disease) at the Hamamatsu University School of Medicine in Japan, and his M.D. in Fujian Medical University in China. He also received postdoctoral training in the Howard Hughes Medical Institute (HHMI) in Dallas, USA. Jason further pursued his MBA study at the Rotman School of Management, University of Toronto.

Jason is fluent in English, Japanese, and Chinese.