Regulatory Affairs Principal, Pharmaceutical and Combination Products

The Regulatory Affairs Principal will provide strategic regulatory leadership to support the development, approval, and lifecycle management of pharmaceutical and combination drug-device products. This individual will serve as a key regulatory partner to cross-functional teams, with a primary focus on FDA CDER interactions, IND/NDA submissions, and global regulatory strategy.This is a high-impact role for a regulatory professional who thrives in a collaborative environment and wants to shape regulatory strategy for innovative combination products.