Joe Zhou
About Joe Zhou
Joe Zhou is a Senior Director of Regulatory Affairs - CMC at EyePoint Pharmaceuticals, with extensive experience in analytical development and regulatory submissions. He has held key positions at various pharmaceutical companies, contributing to successful FDA approvals and compliance with regulatory standards.
Current Role at EyePoint Pharmaceuticals
Joe Zhou serves as the Senior Director of Regulatory Affairs - CMC at EyePoint Pharmaceuticals. He has held this position since 2020, contributing to the company's regulatory strategies and compliance efforts. His role involves overseeing the preparation and submission of regulatory documents, ensuring alignment with FDA guidelines, and managing CMC-related activities. Zhou's expertise is crucial in navigating complex regulatory landscapes to support the development and approval of pharmaceutical products.
Previous Experience in Regulatory Affairs
Before joining EyePoint Pharmaceuticals, Joe Zhou held several key positions in regulatory affairs and analytical development. He worked as the Director of Analytical Development at Entasis Therapeutics from 2019 to 2020 and at Astria Therapeutics, Inc. from 2015 to 2017. His experience includes leading the preparation and submission of CMC sections for IND applications and amendments, particularly for EYP-1901, under tight timelines and limited resources.
Analytical Development Background
Joe Zhou has a strong background in analytical development, having served as Associate Director at Merck from 2012 to 2015 and as a Senior Scientist at Concert Pharmaceuticals, Inc. in 2011. His responsibilities included performing regulatory assessments for post-approval CMC changes for products like YUTIQ® and DEXYCU®, which resulted in multiple FDA approvals. Zhou's analytical expertise has been instrumental in ensuring compliance with regulatory standards.
Education and Academic Credentials
Joe Zhou earned his Ph.D. from the Institute of Applied Chemistry at the Chinese Academy of Sciences. He also studied at The University of Kansas, where he gained foundational knowledge that supports his extensive career in regulatory affairs and analytical development. His academic background provides a solid basis for his work in the pharmaceutical industry.
Regulatory Compliance and Quality Systems
In his career, Joe Zhou has focused on regulatory compliance and quality systems within the pharmaceutical sector. He has conducted due diligence on FDA guidance related to drug-device combination products and performed gap and risk assessments to enhance quality systems. His collaborative efforts with stakeholders have led to refined documentation procedures that align with FDA expectations.