Senior Director Regulatory Affairs

Senior Director, Regulatory Affairs - Hybrid NYC Area

Key Responsibilities

• Develop and execute regulatory strategies supporting clinical development and future product approvals.


• Lead and support preparation and submission of regulatory filings, including INDs, NDAs, and international submissions.


• Provide regulatory guidance to cross-functional teams throughout the product development lifecycle.


• Ensure compliance with FDA and global regulatory requirements while monitoring evolving regulations and industry guidance.


• Identify regulatory risks and develop mitigation strategies.


• Support regulatory aspects of quality systems, including GCP and GLP compliance.

Qualifications

• Advanced degree with 10+ years of regulatory affairs experience, or Bachelor's degree with 12+ years of relevant experience.


• Strong knowledge of FDA and global regulatory frameworks (including Europe and Asia-Pacific markets).


• Proven experience developing regulatory strategy and managing clinical regulatory submissions.


• Excellent communication, collaboration, and project management skills.


• Ability to operate as a senior individual contributor in a fast-paced biotech or pharmaceutical environment.


• Oncology regulatory experience is required.