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