Regulatory Affairs Manager - CMC & Labeling

Role: Regulatory Affairs Manager specializing in CMC for biopharma products, focusing on global regulatory submissions and compliance. Responsibilities: lead preparation and review of regulatory dossiers (INDs, NDAs, BLAs) for US, EU, and ROW, ensuring alignment with quality and regulatory standards; collaborate with manufacturing, quality, and project teams for strategic CMC and labeling planning; manage and mentor regulatory staff; oversee labeling activities, document updates, and dossier management; implement new regulatory practices and technologies. Requirements: Bachelor's in science, 8+ years (or 6+ with Master's, 2+ with PhD/PharmD) in regulatory CMC; extensive experience with electronic publishing tools (eCTDs), document management systems, and pharma software; strong organizational and communication skills. Preferred: advanced degrees (MS, PhD, PharmD), experience with biologics, drugs, devices, and operational systems (Trackwise, LIMS). HighValue: biopharma (drugs, biologics, devices), global regulatory strategy, CMC, labeling, IND/NDA/BLA, 8+ years experience. WorkSetup: hybrid Durham, NC; up to 10% travel; relocation support may be available.