FDA Licenses and Lisoning

Alpha Pharma Healthcare; Thane, Mumbai; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Alpha Pharma Healthcare is seeking an experienced Licensing & Regulatory Affairs Specialist in India to navigate the regulatory landscape under the Drugs and Cosmetics Act, NDCTR, and CDSCO guidelines. The role requires hands-on submission work, documentation, and liaison with CDSCO, State FDA authorities, and internal teams.

The successful candidate will manage CT applications, product permissions, and export NOC processes, ensuring timely approvals and ongoing regulatory compliance across

Qualifications

• Hands-on experience with Indian regulatory applications including CDSCO/DCGI CT submissions
• Familiarity with SUGAM portal submissions and NDCTR guidelines
• Ability to coordinate with State FDA authorities and QA/Production teams

Responsibilities

• Prepare, compile and submit Clinical Trial applications to CDSCO/DCGI
• Prepare and submit applications for product permissions and regulatory approvals
• Manage regulatory submissions through CDSCO/SUGAM portal and track through approval process
• Coordinate with CDSCO/DCGI and respond to regulatory queries and deficiencies
• Coordinate CT applications, amendments and related submissions with CDSCO
• Prepare and submit Export NOC applications and coordinate with authorities for approvals
• Liaise with State FDA authorities regarding licences, permissions and inspections
• Prepare and maintain applications for manufacturing, import, sale/distribution licences
• Monitor regulatory status, timelines and commitments
• Prepare regulatory correspondence and supporting documentation

Skills

Regulatory affairs

CDSCO/DCGI

CT applications

Export NOC

Job description

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