Regulatory Manager

1 week ago

Vapi, Gujarat, India Meril Full time ₹ 12,00,000 - ₹ 36,00,000 per year

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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