CMC Regulatory Manager, Cell & Gene Therapy
Job in
Edison, Middlesex County, New Jersey, 08818, USA
Listed on 2026-08-26
Listing for:
Legend Biotech US
Full Time
position Listed on 2026-08-26
Job specializations:
-
Management
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Healthcare
Job Description & How to Apply Below
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
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