Regulatory Affairs Director - NCE NDA Expert

A leading biopharmaceutical firm in New Jersey is seeking an experienced Regulatory Affairs Director to manage NDA submissions for a late-stage program. This hands-on role requires a minimum of 10 years in Regulatory Affairs, with direct experience in 505(b)(1) NCE NDA submissions. The candidate will lead cross-functional teams and ensure compliance with FDA regulations. The position offers a hybrid work environment and a competitive salary range of $200 to $245K, along with comprehensive benefits. #J-18808-Ljbffr