Cindy Cao | Executive Director & Head of US Regulatory Affairs for Biopharmaceuticals

Cindy Cao, Executive Director & Head of US Regulatory Affairs for Biopharmaceuticals, Sandoz

Dr. Cindy Cao is the Head of US Regulatory Affairs, Sandoz Biopharmaceutical, a Novartis Division. She oversees the Sandoz US regulatory affair biopharm department for all US regulatory activities to support the Sandoz Biosimilar development and commercialization. Dr. Cao provides regulatory strategic counsel to the Sandoz Executive Committee of the Commercial Operations, Intellectual Property, General Legal, Clinical Development, Business Development, Technical Operations. With 16 years of pharmaceutical R & D experience, Dr. Cao has played a leadership role in sanofi, Novo Nordisk, BMS and recently Sandoz, a Novartis Division. She accumulated extensive experience with clinical, nonclinical, CMC and device aspects of development projects as well as marketed products. Dr. Cao has functioned as both global and US regulatory lead and led a number of BLAs and 501(k) filings to FDA approval.
Prior to joining the pharmaceutical industry, Dr. Cao was an Assistant Professor in University of Utah, conducting basic biological research in inflammation and cancer biology. Dr. Cao holds a Ph. D in Biomedical Science and completed an NIH sponsored post-doctoral fellowship.

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