CMC Regulatory Manager, Cell & Gene Therapies

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

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Paid parental leave

Job summary

Legend Biotech in Bridgewater, New Jersey, seeks a Manager, Regulatory CMC to drive global regulatory strategies for pipeline cell and gene therapies, with a strong focus on dossier authoring and cross-functional collaboration. You will coordinate submissions and maintain high-quality regulatory documents to support development and commercialization.

The role requires 5+ years in biotechnology/pharma, with CMC experience, and familiarity with FDA, EMA, and ICH guidelines. A MS/PhD is preferred.

Qualifications

• Bachelor's degree in Life Sciences or related field; advanced degree preferred.
• 5+ years biotechnology/pharma experience with strong technical background.
• 1–2 years Regulatory CMC experience with biologics or cell/gene therapy.
• Experience with process development, analytical development, or manufacturing teams.
• Experience with FDA, EMA, ICH guidelines.

Responsibilities

• Support global CMC regulatory strategies for pipeline cell and gene therapy programs.
• Coordinate CMC components of regulatory submissions (INDs, CTAs, BLAs, MAAs, amendments, supplements, and responses).
• Author, review, and maintain CMC regulatory documentation to support global development and commercialization.
• Collaborate with cross-functional teams including Process Development, Manufacturing, Analytical Development, and QA.
• Translate complex CMC data into clear, scientifically sound regulatory submissions.

Skills

Regulatory CMC

Biologics

Cell & Gene Therapy

Regulatory Submissions

Technical Writing

Cross-functional Collaboration

Project Management

Regulatory Knowledge

Education

Bachelor's in Life Sciences

MS/PhD preferred

Job description

Legend Biotech in Bridgewater, New Jersey, seeks a Manager, Regulatory CMC to drive global regulatory strategies for pipeline cell and gene therapies, with a strong focus on dossier authoring and cross-functional collaboration. You will coordinate submissions and maintain high-quality regulatory documents to support development and commercialization.

The role requires 5+ years in biotechnology/pharma, with CMC experience, and familiarity with FDA, EMA, and ICH guidelines. A MS/PhD is preferred.