Director, Regulatory Strategy Leader

Director, Regulatory Strategy Leader - 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 8 years of regulatory affairs experience, or Bachelor's degree with 10 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.