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 programsDrive NDA preparation, submission, review, and approval activitiesProvide strategic regulatory guidance throughout clinical developmentServe as the regulatory representative on cross-functional program teamsLead interactions with FDA and support regulatory agency communicationsContribute to labeling strategy and lifecycle management activitiesPartner with Clinical, Medical, Commercial, and CMC stakeholders to advance regulatory objectivesQualifications:10+ years of Regulatory Affairs experience within biotechnology or pharmaceuticalsDemonstrated NDA submission experience is requiredStrong Regulatory Strategy background across clinical development and registration activitiesExperience supporting FDA interactions and major regulatory submissionsOncology experience preferredLabeling and/or Ad/Promo experience is a plus