Regulatory Affairs Director

Role: Senior Manager, Regulatory Affairs, leading global regulatory strategies for drug/device combination products and pharmaceuticals. Responsibilities: develop and implement regulatory plans; prepare and oversee high-quality submissions including INDs, NDAs, and CTAs; lead interactions with FDA, EMA, and other authorities; ensure regulatory compliance and alignment across cross-functional teams; mentor junior staff; stay current with global regulatory trends. Requirements: Bachelor’s in science; 9+ years in life sciences, with 6+ years focused on regulatory affairs for pharmaceuticals and combination products; experience in IND/ NDA submissions and agency interactions; knowledge of FDA/ICH, EU regulations, GxPs; strong communication, project management, and leadership skills. Preferred: MS, PharmD, PhD; RAC certification. HighValue: experience with combination products, global regulatory strategy, IND/ NDA preparation, FDA/EMA engagement. WorkSetup: hybrid Aliso Viejo, CA.