Sai Prathyusha Bhamidipati is a seasoned regulatory affairs professional with extensive experience in Chemistry, Manufacturing, and Controls (CMC) within the biopharmaceutical industry. She has held key positions at leading companies, including Moderna, Inc., Vertex Pharmaceuticals, Sage Therapeutics, and Amgen Inc., where she has been instrumental in leading and developing strategies for Biologics License Applications (BLAs) for novel therapeutic products. Sai is recognized for her ability to navigate complex regulatory landscapes and her commitment to advancing regulatory practices.
It is imperative to understand the various regulatory variations globally, develop a strategy for new technologies, engage in harmonization activities, and implement risk management measures.