About the Role

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

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, Current Drugs and Clinical Trials Rules (NDCTR), CDS

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