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Michele Anderson

Head Of Regulatory Affairs at HI-Bio

Michele Anderson is an accomplished professional in regulatory affairs with extensive experience in the biopharmaceutical industry. Currently serving as Head of Regulatory Affairs and Senior Vice President at HI-Bio, a Biogen Company since July 2023, Michele previously held the position of Chief Development Officer at Assembly Biosciences, Inc., from November 2019 to July 2023, overseeing clinical development for HBV and Herpes programs. Prior to that, Michele worked at Gilead Sciences for a decade, advancing through roles such as Executive Director and Senior Director, leading regulatory affairs in liver diseases, inflammation, and oncology. Michele's earlier roles include Senior Manager at CV Therapeutics, where responsibilities included regulatory support for the NDA of Lexiscan, and Manager at IMPAX Laboratories, focusing on abbreviated new drug applications. Michele holds a BS in Biological Sciences from California Polytechnic State University-San Luis Obispo.

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