Bingwu Yu
Director, Regulatory Cmc @Ultragenyx
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WORK HISTORY
Director, Regulatory Cmc @Ultragenyx
RA CMC lead for global CTA including FIH and late phase CMC submission for gene therapy (AAV)• RA CMC support mAb BLA and MAA module 3 preparation and respond HA queries. • Determine global RA CMC strategy. Customize contents plan for M3 documents, review and approve M3 for submission • Interact with global health authorities to respond queries • lead global HA meetings (FDA, EMA, MHRA, PMDA etc.) • Represent RA and provide regulatory guidance/training to multifunction teams• Interact with cross-functional groups and coordinate team members to comply with project timeline• Develop and maintain internal module 3 templates
EDUCATION
Chinese Acadmy of Sciences
Ph. D
ABOUT BINGWU YU
10+ years global regulatory affairs CMC experience and ex-FDA CMC reviewer • Global…
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