Director, Regulatory Affairs

Role: Director, Regulatory Affairs at a clinical-stage biopharma leveraging innovative microscopy technology for drug discovery. Responsibilities include shaping and executing regulatory strategies, supporting INDs/NDAs/MAAs, ensuring compliance with FDA and global regulations, and collaborating with Clinical Development, R&D, and Quality teams throughout the development lifecycle. The role emphasizes strategic guidance and hands-on regulatory support, risk assessment, and maintaining current regulatory knowledge. Qualifications: 10+ years of regulatory affairs experience with a post-graduate degree or 12+ years with a bachelor’s; expertise in FDA and international regulatory frameworks; prior involvement in clinical regulatory content and submissions; excellent communication skills. Preferred: experience supporting oncology development programs. HighValue: clinical-stage, oncology-related programs, cross-functional collaboration, international regulatory requirements (EU, Japan, China), GxP compliance, and a hybrid onsite presence in Jersey City, NJ, requiring a minimum of 3 days/week onsite.