CMC Regulatory Manager, Cell & Gene Therapy

Legend Biotech US; New Jersey; On-site; USD 127,000 - 167,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid parental leave

Paid time off

Job summary

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

Qualifications

• Bachelor's degree in Life Sciences or related; advanced degree preferred.
• 5+ years in biotech/pharma with strong technical background.
• 1-2 years Regulatory CMC experience with biologics or gene therapies.
• Experience with process development, analytical development, or manufacturing teams.
• Knowledge of FDA, EMA, and ICH guidelines.
• Excellent technical writing and ability to translate data into regulatory submissions.
• Strong project management and ability to handle multiple programs.

Responsibilities

• Develop and execute global CMC regulatory strategies for pipeline programs including CAR-T and gene therapy.
• Coordinate and author CMC components of global regulatory submissions (INDs, CTAs, BLAs, MAAs).
• Maintain high-quality CMC regulatory documentation for development, registration and commercialization.
• Collaborate with Process Development, Manufacturing, Analytical Development, and Quality.
• Translate complex CMC data into clear, scientifically sound regulatory submissions.
• Support regulatory impact assessments and submission strategies with cross-functional teams.

Skills

Regulatory CMC expertise

Technical writing

Cross-functional collaboration

Project management

Regulatory submissions

Education

Bachelor's degree in Life Sciences or related

MS/PhD preferred

Tools

Regulatory information management systems

Job description

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