NDA Submissions Director - Regulatory Lead (Hybrid NJ)

A leading biopharmaceutical firm located in South Brunswick, NJ, is seeking an experienced Regulatory Affairs Director to manage 505(b)(1) NDA submissions and lead cross-functional teams. The ideal candidate will possess at least 10 years of experience in Regulatory Affairs, specifically handling NDA modules and regulatory strategies. The position requires a strong knowledge of FDA regulations and the ability to work effectively in a lean biotech environment. A hybrid work model is offered, with significant in-office hours in NJ. #J-18808-Ljbffr