Senior Director Regulatory Affairs

Senior Director, Regulatory Affairs - Hybrid NYC AreaKey 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.