Regulatory CMC Sr. Manager – Global Cell & Gene Therapy

BioNJ Inc.; New Jersey; Sur place; USD 140 000 - 190 000; Plein temps

Résumé du poste

Legend Biotech is seeking a Sr. Manager, Regulatory CMC to join our Regulatory Affairs team in Somerset, NJ. This role focuses on global CMC strategies, dossier authoring, and cross‑functional collaboration to advance development milestones.

The successful candidate will collaborate with development, manufacturing, analytics, and quality teams to ensure compliant submissions for biologics and cell/gene therapies, supporting INDs, CTAs, and related regulatory activities.

Qualifications

• Bachelor's degree in Life Sciences or related field; MS/PhD preferred.
• 5+ years in biotech/pharma with strong regulatory CMC background.
• Experience supporting biologics, cell or gene therapies in submissions.
• Experience working with Process Development, Manufacturing, Analytics, and QA.

Responsabilités

• Support global CMC regulatory strategy development and execution for cell and gene therapy programs.
• Coordinate CMC components of regulatory submissions (INDs, CTAs, BLAs, MAAs, amendments, responses).
• Author, review, and maintain high‑quality CMC regulatory documentation.
• Collaborate with Process Development, Manufacturing, Analytical Development, and QA to translate data into submissions.
• Evaluate technical documentation to support regulatory decisions and submission strategies.

Connaissances

Regulatory CMC experience

Biotech/pharma experience

Regulatory submissions

Cross-functional collaboration

Project management

Formation

Bachelor's degree in Life Sciences

MS/PhD preferred

Description du poste

Legend Biotech is seeking a Sr. Manager, Regulatory CMC to join our Regulatory Affairs team in Somerset, NJ. This role focuses on global CMC strategies, dossier authoring, and cross‑functional collaboration to advance development milestones.

The successful candidate will collaborate with development, manufacturing, analytics, and quality teams to ensure compliant submissions for biologics and cell/gene therapies, supporting INDs, CTAs, and related regulatory activities.