Jay Samudralwar, Ph.D.

Director, Regulatory Affairs

Jay received his Ph.D. in Analytical Chemistry from India and completed his post-doctoral training at University of Kentucky, Lexington. Jay has over 17 years’ experience in Global Regulatory CMC & Conformance, Quality Operations and Quality Control in Pharmaceutical & Biotechnology Industry. He started is pharmaceutical career at Merck and subsequently worked at Wyeth/Pfizer. Jay has a proven track record of developing global regulatory strategies, execution, eCTD submissions and direct interactions with the Boards of Health for developmental / established products (Branded & Generics). He has led technology & site transfer projects for APIs, sterile, non-sterile, biotechnology products and supported PAI/cGMP inspections with successful outcomes.