Senior Director Regulatory Affairs

Job Description

Senior Director, Regulatory Affairs - Hybrid NYC Area

Key Responsibilities

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• Develop and execute regulatory strategies supporting clinical development and future product approvals.
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• Lead and support preparation and submission of regulatory filings, including INDs, NDAs, and international submissions.
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• Provide regulatory guidance to cross-functional teams throughout the product development lifecycle.
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• Ensure compliance with FDA and global regulatory requirements while monitoring evolving regulations and industry guidance.
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• Identify regulatory risks and develop mitigation strategies.
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• Support regulatory aspects of quality systems, including GCP and GLP compliance.
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Qualifications

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• Advanced degree with 10+ years of regulatory affairs experience, or Bachelor's degree with 12+ years of relevant experience.
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• Strong knowledge of FDA and global regulatory frameworks (including Europe and Asia-Pacific markets).
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• Proven experience developing regulatory strategy and managing clinical regulatory submissions.
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• Excellent communication, collaboration, and project management skills.
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• Ability to operate as a senior individual contributor in a fast-paced biotech or pharmaceutical environment.
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• Oncology regulatory experience is required.
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