Spotlight Innovation, a pharmaceutical company advancing technologies designed to address rare, emerging and neglected diseases, has announced the appointment of Chitra Edwin, Ph.D., RAC, as senior vice president of Regulatory Affairs and Compliance. Dr. Edwin will provide leadership for all U.S. and international regulatory matters including strategic planning for regulatory approvals, preparation of regulatory submissions, serving as the primary contact with the FDA and other regulatory authorities, and ensuring compliance with regulatory requirements.
Dr. Edwin has two decades of regulatory affairs, regulatory compliance and quality systems experience, and has been a key member in the development of infectious disease, oncology and cardiology products that have secured regulatory approval for commercialization. She has established and managed regulatory compliant (GLP) testing laboratories, multidisciplinary teams and CROs, and has initiated CLIA accreditation.
Commenting on her new role, Dr. Edwin said, "It is truly a privilege to join Spotlight Innovation. I am pleased to be a member of this motivated and enthusiastic team, and am eager to make a contribution to our efforts to advance our product development programs."
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, is an Adjunct Associate Professor at the College of Pharmacy, University of Cincinnati, and was the Director, Capstone Project, Master's in Drug Development Program.