Nirav Bhatt

About Nirav Bhatt

Seasoned regulatory affairs professional with over 25 years of experience in pharmaceuticals and life sciences, specializing incompliance, risk management, and global product registrations across diverse product categories including Drugs, FSSAI, Ayurvedic, and Medical Devices. Committed to building robust Regulatory frameworks that foster Innovation, Operational Excellence, and continuous improvement. Passionate about guiding cross-functional teams to achieve Regulatory Compliance and Business Continuity.

Experience

1. Head of Regulatory Compliance

   Abbott

   May 2025 — Present · Mumbai, IN

   Led end-to-end product regularization and lifecycle compliance across multiple categories—Drugs, Vaccines, FSSAI, Ayurvedic, and Cosmetics—ensuring seamless adherence to DCGI, FSSAI, and Indian Pharmacopoeia regulations.Headed the Regulatory Affairs Compliance team, ensuring strict adherence to local and international regulations as well as internal governance policies across multiple product lines.Implemented strategic process improvements that significantly accelerated product approval timelines and overall speed-to-market efficiency across divisions.Oversaw digital Patient Information Leaflet (PI) implementation, enhancing accessibility, regulatory compliance, and accuracy of critical patient communication materials.Streamlined regulatory processes, improving manufacturing capacity, reducing operational costs, and enabling more efficient cross-functional collaboration.Streamlined pharmacovigilance regulatory processes, ensuring timely PSUR/ASR reviews and monthly product list updates, enhancing compliance tracking and reducing regulatory bottlenecks.

Education

• Maninagar Science College - India

  Bachelor of Science, Chemistry