Regulatory CMC Manager, Cell & Gene Therapies

BioSpace; 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

PTO, holidays, and flexible benefits

Job summary

Legend Biotech in Somerset, New Jersey seeks a Manager, Regulatory CMC to lead global CMC regulatory strategies and drive high-quality regulatory submissions for cell and gene therapy programs.

You will partner with Regulatory CMC Leads and cross-functional experts to plan, prepare, and coordinate CMC components for INDs, CTAs, and other submissions, ensuring compliance with FDA/EMA/ICH guidelines and company standards.

Qualifications

• Bachelor's degree in Life Sciences or related field required; advanced degree preferred.
• 5+ years in biotech/pharma with strong technical background.
• 1–2 years Regulatory CMC experience for biologics/cell and gene therapy.
• Experience with process development, analytical development, or manufacturing teams.
• Experience supporting cell and gene therapies preferred.
• Familiarity with FDA, EMA, ICH guidelines.
• Excellent technical writing and ability to translate data into regulatory documentation.

Responsibilities

• Develop and execute global CMC regulatory strategies for pipeline programs (CAR-T, lentiviral vectors).
• Coordinate CMC submissions: INDs, CTAs, BLAs, MAAs, amendments, responses to authorities.
• Author and review CMC docs to support development, registration, and commercialization.
• Collaborate with Process Development, Manufacturing, Analytical Development, and Quality teams.
• Translate complex CMC data into clear regulatory submissions.
• Support regulatory decision-making with interpretation of technical documentation.

Skills

Regulatory writing

Cross-functional collaboration

Project management

Regulatory strategy

Communication skills

Education

Bachelor's degree in Life Sciences or related field

Advanced degree (MS/PhD/PharmD) preferred

Job description

Legend Biotech in Somerset, New Jersey seeks a Manager, Regulatory CMC to lead global CMC regulatory strategies and drive high-quality regulatory submissions for cell and gene therapy programs.

You will partner with Regulatory CMC Leads and cross-functional experts to plan, prepare, and coordinate CMC components for INDs, CTAs, and other submissions, ensuring compliance with FDA/EMA/ICH guidelines and company standards.