Regulatory Affairs Manager
Legend Biotech US
Legend Biotech US in Somerset, NJ is seeking a Manager, Regulatory CMC to lead global CMC regulatory strategies for pipeline cell and gene therapy programs, including CAR-T products, with a focus on dossier authoring and cross‑functional collaboration. You will partner with Regulatory CMC Leads, Process Development, Analytical Development, and Manufacturing to prepare submissions (INDs, CTAs, BLAs, MAAs), oversee documentation quality, and ensure compliance with FDA, EMA, and ICH guidelines #J-18808-Ljbffr
Vacancy posted 7 hours ago
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