Janice Sich, M.S.

Regulatory

Janice worked in the pharmaceutical and medical device industries for 25+ years with approximately 20 of those years in Regulatory Affairs while at Bayer, Pfizer and GE Healthcare. Her regulatory work includes interfacing with regulatory authorities at all stages of clinical development to ensure future regulatory success. This includes direct experience interfacing with US FDA (CBER / CDER or CDRH) as well as experience with ex-US Health Authorities. She has experience in providing regulatory guidance to clinical teams so as to reach company goals related to regulatory timelines, develop worldwide regulatory strategy. She coordinates the preparation of information for meetings with drug regulatory agencies as well as the preparation, management and oversight of U.S. and international regulatory submissions for products in development and products that are post-approval. She has a Master’s degree in Chemistry from Loyola University of Chicago.