Manager, Regulatory CMC
Legend Biotech
August 21, 2026
Remote friendly (Somerset, NJ)
United States
Operations
Role Overview
Support the development and execution of global CMC regulatory strategies for pipeline programs, focusing on regulatory dossier authoring and cross-functional collaboration.
Key Responsibilities
- Develop and execute global CMC regulatory strategies for pipeline cell and gene therapy programs (e.g., CAR-T and lentiviral vector products).
- Plan, prepare, review, and coordinate CMC components of global regulatory submissions (INDs, CTAs, BLAs, MAAs, amendments/supplements, and responses to Health Authority requests).
- Author, review, and maintain high-quality CMC regulatory documentation to support global development, registration, and commercialization.
- Collaborate with Process Development, Manufacturing, Analytical Development, and Quality to translate complex CMC information into clear regulatory submissions.
- Evaluate and interpret technical documentation (development reports, validation protocols/reports, comparability assessments, manufacturing change packages) to support regulatory impact assessments and decision-making.
Requirements
- Bachelor’s degree in Life Sciences/Biotech/Pharmaceutical Sciences/Biochemistry/Chemistry/Engineering or related; MS/PhD/PharmD preferred.
- 5+ years in biotechnology or pharmaceutical industry with strong technical background.
- 1–2+ years of Regulatory CMC experience for biologics/cell and gene therapy, or extensive experience authoring/managing CMC sections.
- Experience with process development, analytical development, or manufacturing teams.
- Cell and gene therapy experience highly preferred.
- Familiarity with FDA/EMA/ICH guidelines.
- Strong technical writing; ability to interpret scientific/technical data and translate it into regulatory documentation.
- Strong project management, organizational, communication, and collaboration skills.
Benefits
- Base pay range: $127,313–$167,099 (USD). Other pay may include performance bonus and/or equity.
- Medical/dental/vision; 401(k) match; 8 weeks paid parental leave after 3 months; paid time off (vacation, personal, sick, floating holidays, 11 company holidays). Additional voluntary benefits available.
Support the development and execution of global CMC regulatory strategies for pipeline programs, focusing on regulatory dossier authoring and cross-functional collaboration.
Key Responsibilities
- Develop and execute global CMC regulatory strategies for pipeline cell and gene therapy programs (e.g., CAR-T and lentiviral vector products).
- Plan, prepare, review, and coordinate CMC components of global regulatory submissions (INDs, CTAs, BLAs, MAAs, amendments/supplements, and responses to Health Authority requests).
- Author, review, and maintain high-quality CMC regulatory documentation to support global development, registration, and commercialization.
- Collaborate with Process Development, Manufacturing, Analytical Development, and Quality to translate complex CMC information into clear regulatory submissions.
- Evaluate and interpret technical documentation (development reports, validation protocols/reports, comparability assessments, manufacturing change packages) to support regulatory impact assessments and decision-making.
Requirements
- Bachelor’s degree in Life Sciences/Biotech/Pharmaceutical Sciences/Biochemistry/Chemistry/Engineering or related; MS/PhD/PharmD preferred.
- 5+ years in biotechnology or pharmaceutical industry with strong technical background.
- 1–2+ years of Regulatory CMC experience for biologics/cell and gene therapy, or extensive experience authoring/managing CMC sections.
- Experience with process development, analytical development, or manufacturing teams.
- Cell and gene therapy experience highly preferred.
- Familiarity with FDA/EMA/ICH guidelines.
- Strong technical writing; ability to interpret scientific/technical data and translate it into regulatory documentation.
- Strong project management, organizational, communication, and collaboration skills.
Benefits
- Base pay range: $127,313–$167,099 (USD). Other pay may include performance bonus and/or equity.
- Medical/dental/vision; 401(k) match; 8 weeks paid parental leave after 3 months; paid time off (vacation, personal, sick, floating holidays, 11 company holidays). Additional voluntary benefits available.