Licensing & Regulatory Specialist

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 / new 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), CDSCO guidance and applicable State FDA requirements.
• Keep the company informed of changes in Indian pharmaceutical regulatory requirements and procedures.
• Coordinate with internal QA, QC, R&D, Production and Business Development teams to obtain information required for regulatory submissions.
• Assist with regulatory inspections, audits and interactions with regulatory authorities when required.

Key Requirement Clinical Trial & Product Applications

Candidates should have demonstrable hands-on experience with Indian regulatory applications, including familiarity with:

• CDSCO/DCGI CT application procedures
• SUGAM portal submissions
• Preparation and compilation of CT application dossiers
• Product permission / new drug permission applications
• Regulatory documentation and submission requirements
• Responding to CDSCO/DCGI queries and deficiencies
• Clinical Trial permissions and amendments
• Export NOC applications and procedures
• Regulatory correspondence and follow-up with CDSCO and State FDA authorities