Dr. Chitra Edwin, PhD
Dr. Chitra Edwin, is a regulatory affairs and compliance professional with over two decades of experience in the biotechnology, and diagnostics private sector. She has been a key team leader in the product development of approved, infectious diseases, oncology and cardiology products. She has held leadership positions in the biopharmaceutical, and diagnostic industry including Spotlight Innovation, the Cleveland Heart Lab (Quest Diagnostics), Mass Biologics, and Chiron Corporation (Novartis). She is an Adjunct Associate Professor of Pharmaceutical Sciences, and was the Director of the Capstone Project, Master’s in Drug Development Program, College of Pharmacy, University of Cincinnati. She was the Biopharmaceutical Board member of the Opus Institutional Review Board. She has successfully established, and managed multidisciplinary, multinational teams. She is an entrepreneur, and founder of Biotechnology Consulting Solutions, Ltd., and co-founder of non-profit organizations on science, and international business including the India-US Business Network, and the Graduate Women in Science (GWIS) Massachusetts chapter. She has been an invited speaker at Regulatory Affairs conferences.
Dr. Edwin earned her Ph.D. in Medical Microbiology and Immunology from the University of Minnesota, and then trained at the Harvard Medical School as a Post-doctoral Research Fellow at the Brigham and Women’s Hospital and was an Instructor in Medicine at the Dana Farber Cancer Institute. She holds Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.