
Regulatory Manager
5 days ago
Position: Senior Manager Regulatory Affairs
Department: Regulatory Affairs
Location: Vapi, Gujarat
Reports to: Head – Regulatory Affairs / VP Regulatory
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 in cell 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 with cell and gene therapy guidelines 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 and CGT regulatory 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 to cell 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 CDSCO CGT guidelines.
- 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
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