Jay Samudralwar, Ph.D.

Jay Samudralwar, Ph.D. has extensive experience in regulatory affairs and compliance within the pharmaceutical and biotech industry. Jay currently holds the position of Vice President, Regulatory Affairs - CMC at Syner-G BioPharma Group, where they manage pre-clinical to Phase III development and post-approval products for biotech and pharmaceutical clients. Jay provides end-to-end support, including regulatory strategy, dossier planning, authoring, review, submission, and communication with agencies.

Prior to their current role, Jay worked at Pfizer Inc. as an Associate Director and later as a Manager/Senior Manager in Global Regulatory & Conformance. Jay was responsible for globally registered products, including sterile injectables, non-sterile products, and biotechnology products. Jay planned and executed submissions and communicated with regulatory agencies worldwide.

Additionally, Jay held the position of Senior Regulatory Scientist at Merck & Co., where they supported a portfolio of sterile injectable and non-sterile products. Jay led regulatory submissions for the approval of an oncology product and managed the submission process for investigational new drug (IND) applications.

Earlier in their career, Jay worked as a Sr. Validation Scientist at Wyeth-Ayerst and as a Bioanalytical Scientist at Merck & Co. In these roles, they conducted quality control testing, coordinated stability studies, developed validation protocols and methods, and supported regulatory requirements.

Jay began their career as a Supervisor at the Disease Diagnostic Laboratory at the University of Kentucky, where they managed laboratory staff, developed analytical test methods, and communicated with internal and external customers.

Overall, Jay Samudralwar, Ph.D. has a strong background in regulatory affairs, compliance, and scientific research within the pharmaceutical and biotech industry. Their experience spans various stages of drug development and regulatory submissions, making him a valuable asset to any organization.

Jay Samudralwar, Ph.D. began their education in 1984 at Nagpur University in Nagpur. Jay pursued a Master of Science and a Ph.D. in Analytical & Nuclear Chemistry, completing their studies in 1990. Following this, from 1990 to 1993, they attended the University of Kentucky in Lexington, KY, where they served as a Research Associate, continuing their focus on Analytical & Nuclear Chemistry.