Hongmei Li
Director, Regulatory Cmc @89bio
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WORK HISTORY
Director, Regulatory Cmc @89bio
San Francisco, CA, US
Submission Management: Lead preparation of the dossier for CMC updates and responses for Agency\'s RFI- Regulatory Strategy Development: Develop and implement global CMC regulatory strategies for late phase investigational products- Regulatory Compliance: provide regulatory input to ensure manufacturing product and product quality align with regulatory requirements- Change Management: evaluate regulatory impact of changes in manufacturing processes and quality
EDUCATION
Jilin University
B. S., Biotechnology
Jilin University
M. S., Biochemistry & Mol. Biology
Southern Methodist University
Ph. D, Chemistry
ABOUT HONGMEI LI
Regulatory CMC, Ph.D., RAC
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