Kevin L. is an accomplished professional in the field of regulatory affairs, currently serving as the Vice President of US Regulatory Affairs at TopAlliance Biosciences Inc. since January 2023. Prior to this role, Kevin held the position of Executive Director of Regulatory Affairs at 上海君实生物医药科技股份有限公司 from November 2020 to January 2023, and was a Director of Regulatory Affairs at AstraZeneca from May 2018 to November 2020, overseeing regulatory strategies and submissions. Kevin's experience includes roles at the FDA as a CMC Reviewer, where contributions involved reviewing complex submissions for novel biologics and biosimilars. In addition, Kevin has a solid foundation in drug development stemming from positions at MedImmune, where leadership encompassed analytical support for mAb projects, as well as research roles at the University of Maryland and University of Illinois. Kevin earned a Ph.D. in Biotechnology from the University of Illinois Urbana-Champaign and a Bachelor’s degree from Peking University.
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