Manager, Project Management, Regulatory

Role: Regulatory Project Management at Legend Biotech supporting Cell & Gene Therapy programs, focusing on planning, coordination, and documentation of development activities. Responsibilities: manage project timelines and cross-functional collaboration across Research, CMC, Quality, Regulatory, and Clinical teams; facilitate IND submissions; monitor budgets; prepare reports and presentations; ensure documentation accuracy; and support vendor onboarding and communication with external partners. Requirements: Bachelor's in Life Sciences or related field; 1–3 years in project coordination within biotech or pharma, with familiarity in Cell & Gene Therapy, biologics, or related areas preferred; understanding of drug development stages including preclinical, CMC, and IND; strong organizational and communication skills; proficiency in Microsoft Office and project management tools; PMP or CAPM a plus. HighValue: early-career, supporting innovative cell and gene therapies, regulatory filings, cross-functional team engagement, project lifecycle management. WorkSetup: based in Somerset, NJ, with a collaborative environment supporting growth in a fast-paced biotech setting.