Xiaoxuan (Jason) Shen
About Xiaoxuan (Jason) Shen
Xiaoxuan (Jason) Shen serves as the Director of Regulatory Affairs - CMC at Insmed Incorporated, where he develops regulatory strategies and manages submissions for drug products. He holds a Ph.D. in Analytical Chemistry and has extensive experience in regulatory affairs across various companies, including Novartis and Celgene.
Work at Insmed
Xiaoxuan (Jason) Shen has served as the Director of Regulatory Affairs - CMC at Insmed Incorporated since 2021. In this role, he develops regulatory strategies to address challenges in Chemistry, Manufacturing, and Controls (CMC) development. His responsibilities include planning CMC meetings with regulatory agencies and drafting and reviewing regulatory documents. Shen plays a crucial role in ensuring the global approvability of drug products, contributing to the overall success of Insmed's regulatory initiatives.
Education and Expertise
Shen earned his Ph.D. in Analytical Chemistry from the University of New Hampshire, where he studied from 2001 to 2006. He also holds a Bachelor of Science degree in Polymer Physics from the University of Science and Technology of China. His educational background provides a strong foundation for his expertise in regulatory affairs, particularly in managing regulatory submissions for device combination products, including inhalation products.
Background
Before joining Insmed, Shen held various positions in the regulatory field. He worked at Celgene as a Senior Manager in Global Regulatory CMC from 2012 to 2021. Prior to that, he was a Principal Scientist at Novartis from 2006 to 2012. Additionally, he served as an Adjunct Professor at Fairleigh Dickinson University from 2012 to 2015, where he contributed to the academic community while enhancing his professional expertise in regulatory affairs.
Achievements
Shen has extensive experience in managing regulatory submissions and providing interpretation and advice on global regulations from agencies such as the FDA, EMA, ICH, and WHO. His contributions include actively participating in scientific discussions and collaborations to resolve technical and regulatory issues throughout various stages of product development. His work ensures compliance in regulatory filings, which is essential for the successful approval of drug products.