Yanyun (Sherry) Chen
About Yanyun (Sherry) Chen
Yanyun (Sherry) Chen is the Executive Director of Regulatory Affairs at Brii Biosciences, where she has worked since 2020. She holds a Master of Science in Analytical Chemistry and a Master's degree in Regulatory Affairs/Quality Assurance, and has extensive experience in regulatory environments in both the US and China.
Work at Brii Biosciences
Yanyun (Sherry) Chen serves as the Executive Director of Regulatory Affairs at Brii Biosciences, a position she has held since 2020. Based in Shanghai, China, she is responsible for supporting regulatory strategies and managing dossier preparations for the company's innovative products. Her role is critical in ensuring successful regulatory submissions and approvals, which are essential for the advancement of Brii Bio's product pipeline.
Education and Expertise
Yanyun Chen holds a Master of Science in Analytical Chemistry from the University of Louisiana at Monroe and a Master's degree in Regulatory Affairs/Quality Assurance from Temple University. She also earned a Bachelor of Science in International Business/Microbiological Engineering from Zhejiang University of Technology. Her educational background provides a strong foundation for her extensive expertise in regulatory affairs, project management, and compliance with regulatory requirements.
Background in Regulatory Affairs
Yanyun Chen has extensive experience in both the US and Chinese regulatory environments, which is crucial for navigating international pharmaceutical regulations. Prior to her current role, she worked at Sanofi in various capacities, including Head of GRA CMC & Devices China and Director of GRA CMC Biologics China. She also held positions at Pfizer Inc. and Novartis, where she developed a strong analytical background in regulatory compliance and project management.
Professional Experience
Yanyun Chen's professional journey includes significant roles in major pharmaceutical companies. She worked at Pfizer Inc. as a Regulatory Manager and later as a Team Leader/Development Scientist. At Novartis, she served as the RegCMC Group Head. Her experience spans over two decades, with a focus on regulatory compliance, cGMPs, and ensuring adherence to quality standards in pharmaceutical manufacturing.
Specialization in Regulatory Affairs
Yanyun Chen specializes in Regulatory Chemistry, Manufacturing, and Controls (RegCMC), focusing on both development and marketed products. Her expertise involves ensuring compliance with regulatory requirements throughout the product lifecycle. She possesses in-depth knowledge of current Good Manufacturing Practices (cGMPs), which are essential for maintaining quality standards in the pharmaceutical industry.