CMC Regulatory Manager, Cell & Gene Therapy

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

Job summary

Legend Biotech, a global biotechnology company, seeks a Manager, Regulatory CMC in Somerset, NJ. This role supports global CMC strategies for pipeline programs, focusing on dossier authoring and cross-functional collaboration to advance product milestones.

You will partner with Regulatory CMC leads, prepare submissions, and translate complex CMC information into clear regulatory documents. A strong background in biologics or cell/gene therapy and excellent writing are essential.

Qualifications

• Bachelor's degree in Life Sciences or related; advanced degree preferred.
• 5+ years in biotechnology/pharmaceutical industry with regulatory CMC focus.
• Experience supporting biologics or cell/gene therapies and writing submissions.

Responsibilities

• Scale global CMC regulatory strategies for cell/gene therapy programs.
• Coordinate CMC components of submissions (INDs/CTAs/BLAs).
• Author and review high-quality CMC documentation.
• Collaborate with Process Development, Manufacturing, and Analytical teams.
• Interpret technical data for regulatory submissions.

Skills

Regulatory CMC

Biologics knowledge

Cross-functional collaboration

Technical writing

Project management

Education

Bachelor's degree in Life Sciences or related

Advanced degree preferred

Tools

Regulatory submissions

Quality systems awareness

Job description

Legend Biotech, a global biotechnology company, seeks a Manager, Regulatory CMC in Somerset, NJ. This role supports global CMC strategies for pipeline programs, focusing on dossier authoring and cross-functional collaboration to advance product milestones.

You will partner with Regulatory CMC leads, prepare submissions, and translate complex CMC information into clear regulatory documents. A strong background in biologics or cell/gene therapy and excellent writing are essential.