Director Associate Regulatory Affairs at Ultragenyx Pharmaceutical Inc.
Industry
Medical / Health Care / Pharmaceuticals
About
Experienced Regulatory Professional in Biologics, Rx and OTC drug product development, marketing registration, and pre- and post-marketing maintenance: IND/CTA, Drug Master Files, Orphan Applications, Drug Advertising and Promotional Review, Scientific Advice, Marketing Authorization Applications, as well as Supplements, Amendments, Annual Reports/Notifications, Variations, and Renewals. 16 years of experience in the research and development of drugs and biologics, with 11 years in Regulatory, in the areas of Metabolism and Endocrinology, Neurology, Dermatology, Gene Therapy and Cardiovascular. Direct Regulatory experience in leading, overseeing, and/or contributing to the filing of 3 NDA...
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