Jay Samudralwar has more than 20 years of experience in Regulatory CMC, with expertise in submissions for solid orals, liquids, injectables, frozen, and inhalation products across multiple therapeutic areas. Since joining Syner-G in 2020, he has led complex IND/IMPD and NDA/WMA submissions, guiding clients through regulatory challenges to approvals in the US, EU, and global markets.

He is recognized for his team-focused leadership, high client satisfaction, and success managing large-scale contracts involving small molecules, biologics, and regulatory compliance. Jay’s prior experience includes roles at Wyeth, Pfizer, and Merck. He holds a Ph.D. in analytical chemistry from Nagpur University with post-doctoral work at the University of Kentucky.