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
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