Dr. Chitra Edwin, PhD, RAC
Board Member
Dr. Chitra Edwin is an experienced expert in Regulatory Affairs, and Quality Systems in the Life Sciences industry. She was a Senior Principal Advisor, Regulatory Affairs and Quality Systems at Covance by LabCorp. Most recently, she was the Senior Vice President of Regulatory Affairs and Compliance at Spotlight Innovation Inc. She has over two decades of experience in the biotechnology, pharmaceutical and diagnostics private sector, and has been a key member in the development of infectious disease, oncology and cardiology diagnostic, and therapeutic (vaccines) products that have secured regulatory approval. Her areas of expertise include product development, regulatory affairs, regulatory strategy, regulatory compliance and quality systems. Dr. Edwin earned a Ph.D. in Medical Microbiology and Immunology from the University of Minnesota, and then trained at the Harvard Medical School as a Research Fellow at the Brigham and Women’s Hospital, and as an Instructor in Medicine at the Dana Farber Cancer Institute. She holds Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society in US FDA Regulations, and CMC Regulations. She is an Adjunct Professor of Pharmaceutical Sciences at the College of Pharmacy, University of Cincinnati.