Sarah Shi

Sarah Shi is a seasoned professional in global regulatory affairs with extensive experience in the pharmaceutical and biotechnology sectors. Currently serving as Director of Global Regulatory Affairs CMC at BeiGene, Sarah leads a team that manages regulatory strategies and dossier submissions for cancer therapies, including biologics and antibody-drug conjugates. Prior roles include Associate Director of Global Regulatory Affairs CMC at AstraZeneca, where Sarah directed global CMC regulatory strategies across various project stages, and Senior Manager of Regulatory Affairs at Kolon TissueGene, Inc., supporting phase 3 clinical trials. Earlier experience encompasses positions at Prometic Bioproduction Inc., Merck, GSK, Pfizer, and Cleveland Clinic, with a strong background in high-throughput screening, assay development, and biomarker analysis. Sarah holds a Master’s degree in Molecular Biology from Kent State University and a Bachelor’s degree in Biology from Nankai University.