Regulatory Manager

Position: Senior Manager Regulatory Affairs

About the Role

We are seeking a highly skilled and motivated Senior Manager – Regulatory Affairs to lead regulatory strategy, submissions, and compliance for our CAR-T (Chimeric Antigen Receptor T-cell) therapy programs from our Vapi location. The role requires strong expertise incell and gene therapy(CGT) regulations, strategic interactions with regulatory authorities, and cross-functional leadership to enable successful development and commercialization of CAR-T products.

Key Responsibilities

• Develop and implement regulatory strategies for CAR-T therapy products across global markets (US FDA, EMA, CDSCO, and other relevant agencies).

• Lead preparation, review, and submission of regulatory dossiers (IND, IMPD, BLA/MAA, amendments, briefing packages, and responses to authority queries).

• Ensure compliance withcell and gene therapyguidelines including ATMP regulations, ICH, GxP, and CDSCO requirements for India.

• Collaborate with R&D, Quality, Clinical, and Manufacturing teams based in Vapi and other sites to ensure regulatory alignment throughout product lifecycle.

• Manage interactions and represent the company during regulatory authority meetings (pre-IND, end-of-phase, scientific advice, etc.).

• Monitor evolving CAR-T andCGTregulatory landscapes, identify risks, and provide proactive guidance to internal teams.

• Lead, mentor, and develop junior regulatory team members.

Qualifications & Experience

• Master’s/Ph.D. in Life Sciences, Biotechnology, Pharmacy, or related field.

• 10–12+ years of regulatory affairs experience with significant exposure tocell and gene therapy/ biologics; minimum 5 years in a managerial/leadership role.

• Hands-on experience with CAR-T or ATMP submissions (IND/IMPD/BLA/MAA).

• Strong knowledge of FDA, EMA, and CDSCOCGTguidelines.

• Proven track record of successful regulatory authority interactions.

• Excellent leadership, communication, and cross-functional collaboration skills.

Key Competencies

• Strategic and analytical thinking

• Strong scientific and regulatory acumen

• Stakeholder management and influencing skills

• High attention to detail with ability to manage multiple projects

• Leadership in a fast-paced, innovative environment