Job Title

We’re Hiring | Regulatory Affairs – CMC (Cell & Gene Therapy)We are looking for a Regulatory Affairs professional with strong CMC expertise in Cell & Gene Therapy (CGT) to join our growing team. This role offers an exciting opportunity to work on innovative therapies and global regulatory submissions.Role: Regulatory Affairs – CMC (CGT)Location: Mumbai (Maharashtra) // Vapi (Gujarat)Experience: 3–10 yearsKey Responsibilities:Prepare, review, and manage CMC sections for regulatory submissions (IND, CTA, BLA, MAA, etc.) related to Cell & Gene Therapy productsSupport regulatory strategy and documentation for clinical and commercial CGT programsCoordinate with CMC, Manufacturing, Quality, and Analytical teamsEnsure compliance with FDA, EMA, ICH, and other global regulatory guidelinesManage regulatory queries, variations, amendments, and responsesMaintain regulatory documentation and lifecycle management activitiesRequired Skills & Experience:Hands-on experience in Regulatory Affairs – CMCStrong understanding of Cell Therapy / Gene Therapy / ATMPsKnowledge of manufacturing processes, characterization, comparability, and control strategiesExperience with CMC documentation for IND/CTA/BLA submissionsFamiliarity with ICH guidelines (Q-series), FDA, EMA regulationsExcellent communication and cross-functional collaboration skillsPreferred Qualifications:Degree in Pharmacy, Biotechnology, Life Sciences, or related fieldExperience working on CGT products.Exposure to global regulatory submissions is a plus✨ Why Join Us?Work on cutting-edge Cell & Gene Therapy programsCollaborative and growth-oriented environmentOpportunity to build deep expertise in CGT Regulatory CMCInterested candidates: Please share your resume on below mentioned mail id or connect via LinkedIn with a brief summary of your CMC experience in Cell & Gene Therapy.Mail ID :- satyaprakash.sharma@