CMC Regulatory Manager, Cell & Gene Therapy

Legend Biotech USA; New Jersey; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Full-time benefits

Job summary

Legend Biotech USA seeks a Manager, Regulatory CMC to support global regulatory strategies for pipeline programs, focusing on CMC dossier authoring and cross‑functional collaboration to advance development milestones.

The role emphasizes coordinating with Regulatory CMC Leads and cross-functional teams to prepare submissions (INDs, CTAs, BLAs, MAAs) and ensure regulatory compliance across regions.

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Biochemistry, Chemistry, Engineering, or related discipline required.
• Advanced degree (MS, PhD, PharmD) preferred.
• 5+ years of biotechnology or pharmaceutical industry experience with strong technical background.
• 1-2 years of Regulatory CMC experience supporting biologics, cell and gene therapy products or extensive experience authoring and managing CMC sections of regulatory dossiers and submissions.

Responsibilities

• Support development and execution of global CMC regulatory strategies for pipeline cell and gene therapy programs, including CAR-T and lentiviral vector products.
• Coordinate CMC components of global regulatory submissions (INDs, CTAs, BLAs, MAAs, amendments, supplements, responses to Health Authority requests).
• Author, review, and maintain high‑quality CMC regulatory documentation for global development, registration, and commercialization.

Job description

Legend Biotech USA seeks a Manager, Regulatory CMC to support global regulatory strategies for pipeline programs, focusing on CMC dossier authoring and cross‑functional collaboration to advance development milestones.

The role emphasizes coordinating with Regulatory CMC Leads and cross-functional teams to prepare submissions (INDs, CTAs, BLAs, MAAs) and ensure regulatory compliance across regions.