Director, Regulatory Affairs

A commercial-stage biotechnology company focused on oncology and hematology is seeking a Director of Regulatory Affairs to support an expanding portfolio of programs spanning development through commercialization. This individual will play a key role in regulatory strategy and execution, with a primary focus on leading NDA submission activities and supporting programs through approval and post-marketing lifecycle management. The position offers significant visibility across cross-functional teams and the opportunity to impact multiple assets at critical regulatory milestones. Responsibilities: Lead regulatory strategy for development and late-stage programs Drive NDA preparation, submission, review, and approval activities Provide strategic regulatory guidance throughout clinical development Serve as the regulatory representative on cross-functional program teams Lead interactions with FDA and support regulatory agency communications Contribute to labeling strategy and lifecycle management activities Partner with Clinical, Medical, Commercial, and CMC stakeholders to advance regulatory objectives Qualifications: 10+ years of Regulatory Affairs experience within biotechnology or pharmaceuticals Demonstrated NDA submission experience is required Strong Regulatory Strategy background across clinical development and registration activities Experience supporting FDA interactions and major regulatory submissions Oncology experience preferred Labeling and/or Ad/Promo experience is a plus #J-18808-Ljbffr