Michele Anderson is Senior Vice President of Regulatory Affairs at HI-Bio. She has over 25 years of global drug development experience and has managed large international regulatory teams, including in China and Japan. Michele’s experience spans all phases of development, and she has led the global regulatory aspects for several approved products.
Prior to joining HI-Bio, Michele was Chief Development Officer at Assembly Bio, where she led regulatory and clinical development for numerous clinical stage programs. Previously, she was at Gilead Sciences, where she led global regulatory affairs for liver diseases, inflammation and non-cell therapy oncology therapeutic areas, and prior to that, she was at CV Therapeutics and IMPAX Laboratories. In 2019 Michele was named one of the most influential women in Bay Area business by the San Francisco Bay Times. Michele has a BS in Biological Sciences from California Polytechnic State University, San Luis Obispo.