Dr. Chance has over 25 years of work experience in the healthcare industry, including the last 17 years in regulatory affairs at CRO, pharmaceutical and biotechnology industries. She advises biotechnology companies for region specific and/or global regulatory strategy for the development of biosimilars.
Her overall regulatory experience encompasses developing global regulatory strategy, preparation of briefing documents, meetings with FDA, IND/CTA submissions, Marketing Applications (BLAs, MAAs, etc. She has provided global regulatory strategy on number of biosimilar products currently in development and has authored/co-authored number of articles on biosimilars:
Dr. Chance has a Ph.D in Nutrition/Nutritional Biochemistry and Masters of Public Health. She has a Regulatory Affairs Certification from the Regulatory Affairs Professionals Society.