About the Role

We are looking for an experienced Licensing & Regulatory Affairs Specialist with strong practical knowledge of the Indian pharmaceutical regulatory environment.

The ideal candidate should have hands-on experience dealing with CDSCO/DCGI and State FDA authorities, with particular expertise in Clinical Trial (CT) applications, product permissions, regulatory approvals and Export NOCs.

This is a hands-on regulatory role for someone who understands not only the regulatory requirements, but also the actual procedures, documentation, online submissions, follow-up and communication with regulatory authorities.

Key Responsibilities
- Prepare, compile and submit Clinical Trial (CT) applications to CDSCO/DCGI.
- Prepare and submit applications for product permissions / recent drug permissions and related regulatory approvals.
- Manage regulatory submissions through the CDSCO/SUGAM portal and track applications through the approval process.
- Coordinate with CDSCO/DCGI and respond to regulatory queries, deficiencies and requests for additional information.




- Coordinate Clinical Trial applications, amendments and related regulatory submissions with CDSCO.
- Prepare and submit applications for Export NOCs and coordinate with CDSCO and State FDA authorities for obtaining required approvals.
- Liaise with State FDA / State Drug Control Authorities regarding licences, permissions, inspections, renewals and other regulatory matters.
- Prepare and maintain applications and documentation for manufacturing, import, sale/distribution and other pharmaceutical licences, as applicable.
- Monitor regulatory application status, timelines, deficiencies and regulatory commitments.
- Prepare regulatory correspondence, responses to queries and supporting documentation.
- Maintain regulatory files, submission records, licences, approvals and correspondence.
- Interpret applicable requirements under the Drugs and Cosmetics Act/Rules, New Drugs and Clinical Trials Rules (NDCTR), CDS

📌 Licensing & Regulatory Specialist (Saki Naka)
🏢 Alpha Pharma Healthcare
📍 Saki Naka