Astrid Alfaro
Associate Director Regulatory Affairs @BioMarin Pharmaceutical Inc.
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WORK HISTORY
Associate Director Regulatory Affairs @BioMarin Pharmaceutical Inc.
US and ex-US (LATAM and APAC) Regulatory support for Gene Therapy Product. •Supported original BLA Gene Therapy submission and resubmission, Leading Module 1 preparation, regulatory review of Module 2,4,5. • Supported BLA review activities managing FDA information requests and coordination of cross-functional team members to provide responses. FDA Application Orientation Meeting preparation. •Lead preparations of Clinical Trial Applications for Phase 3 Gene Therapy Trial US and ex-US (LATAM and APAC), with CRO partners.
EDUCATION
University of Florida
Bachelors of Science, Biochemistry and Molecular Biology
UC Berkeley Extension
Certificate in Regulatory Affairs
University of California, Berkeley
Doctor of Philosophy (Ph.D.), Cell/Cellular and Molecular Biology
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