Speakers

Michele has over 27 years of regulatory affairs expertise in development and commercialization of new and generic drugs across a wide range of dosage forms and therapeutics areas.
Michele is Director, Regulatory Affairs at Cipla USA where she leads the Regulatory Agency interactions for a large portfolio of drug products and active pharmaceutical ingredients (APIs). She has a broad and deep understanding of the global regulatory approval process, including strategy, submissions, labeling, promotion, and post-marketing requirements. She earned a MS in Chemical & Life Sciences from University of Maryland-College Park and RAC from RAPS.