Job Title: Regulatory Affairs - Executive (CMC) – Cell & Gene Therapy / CAR-T
Location: Vapi
Department: Regulatory Affairs
Experience: 2–6 Years
Employment Type: Full-Time
Job Summary
We are looking for a Regulatory Affairs Executive (CMC) with experience in Cell & Gene Therapy (CGT) and/or CAR-T Cell Therapy. The role involves supporting CMC regulatory submissions, dossier preparation, lifecycle management, and regulatory compliance activities related to manufacturing, quality, and process development.
Key Responsibilities
- Prepare, review, and maintain CMC documentation for regulatory submissions (IND, CTA, BLA, MAA, amendments, and variations).
- Coordinate with cross-functional teams to gather technical data and prepare submission packages.
- Review manufacturing, analytical, quality, validation, stability, and process development documents for regulatory compliance.
- Support responses to regulatory authority queries and health authority inspections/audits.
- Assess regulatory impact of manufacturing changes, technology transfers, process validations, and change controls.
- Support post-approval activities such as variations, amendments, annual reports, renewals, and site changes.
- Track regulatory commitments, submission timelines, and maintain regulatory databases.
- Monitor regulatory updates and provide guidance on Cell & Gene Therapy regulations.
Experience & Technical Expertise
- 2–6 years of Regulatory Affairs (CMC) experience in Cell & Gene Therapy and/or CAR-T Cell Therapy.
- Knowledge of:
- Cell culture and cell processing
- Viral vectors (Lentiviral, Retroviral, AAV)
- CAR-T manufacturing processes
- Process validation and technology transfer
- Stability studies and analytical characterization
- GMP regulations and ICH guidelines
- Module 3 (CMC) documentation
Key Skills
- CMC dossier preparation and regulatory submissions
- Scientific writing and technical documentation
- Regulatory compliance and lifecycle management
- Project coordination and stakeholder management
- Strong analytical and communication skills
- Proficiency in Microsoft Office and document management systems
Qualifications
- M.Pharm, B.Pharm, Pharm.D, M.Sc. Biotechnology/Life Sciences, M.Tech Biotechnology, or equivalent.
- Specialization in Regulatory Affairs, Biotechnology, or Pharmaceutical Sciences preferred.
Industry Preference
Cell & Gene Therapy, CAR-T Therapy, Biotechnology, Biopharmaceuticals
