Regulatory CMC Manager, Cell & Gene Therapy

Socket.dev; New Jersey; On-site; USD 127,000 - 167,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan

Paid parental leave

Paid time off and holidays

Commuter benefits

Job summary

Legend Biotech in Somerset, NJ, is seeking a Manager, Regulatory CMC to lead the development and execution of global CMC regulatory strategies for pipeline cell and gene therapy programs, including CAR-T and viral vectors.

The role involves authoring and reviewing regulatory documents, coordinating with Process Development, Manufacturing, Analytical Development, and Quality teams, and ensuring compliance with FDA, EMA and ICH guidelines.

Qualifications

• Bachelor’s degree in Life Sciences or related field required; advanced degree preferred.
• 5+ years biotech/pharma experience with strong technical background.
• 1–2 years Regulatory CMC experience for biologics, cell or gene therapy.
• Experience coordinating cross-functional teams and regulatory submissions.

Responsibilities

• Develop and execute global CMC regulatory strategies for pipeline cell and gene therapy programs.
• Coordinate CMC components of submissions (INDs, CTAs, BLAs, MAAs, amendments).
• Author, review, and maintain CMC documentation ensuring regulatory compliance.
• Collaborate with Process Development, Manufacturing, Analytical Development, and Quality teams.
• Evaluate technical docs and translate data into regulatory submissions.
• Support regulatory decision-making and submission strategies.

Skills

Regulatory CMC

CMC knowledge

Technical writing

Cross-functional collaboration

Project management

Education

Bachelor's degree in Life Sciences

MS/PhD/PharmD preferred

Job description

Legend Biotech in Somerset, NJ, is seeking a Manager, Regulatory CMC to lead the development and execution of global CMC regulatory strategies for pipeline cell and gene therapy programs, including CAR-T and viral vectors.

The role involves authoring and reviewing regulatory documents, coordinating with Process Development, Manufacturing, Analytical Development, and Quality teams, and ensuring compliance with FDA, EMA and ICH guidelines.