Job Description

Job Title

Head Compliance & Licensing

Location: Satara, Maharashtra

Experience: 3+ Years and above

Qualification: B.Pharm / M.Pharm / M.Sc. (Pharmaceutical Sciences) or equivalent

Job Summary

Lead and manage pharmaceutical licensing, statutory compliance, government liaison, inspections, and regulatory approvals in compliance with the Drugs & Cosmetics Act & Rules, Revised Schedule M, WHO-GMP, CDSCO, State FDA, and other applicable regulations. Ensure timely acquisition, renewal, and maintenance of all statutory licences and approvals while maintaining inspection readiness and zero compliance lapses.

Note: Product registrations, CTD/ACTD dossiers, artwork approvals, and country-specific regulatory submissions are managed by the Regulatory Affairs Department.

Key Responsibilities
Manage WHO-GMP, GMP, COPP, FSC, Manufacturing, Loan, Wholesale, Import, Export, Test Licenses, Product Permissions, and all statutory licence renewals and amendments.
Handle CBN, NDPS, DGFT, FSSAI, MPCB/CPCB, Fire NOC, Factory Act, Customs, IEC, Hazardous Waste,



and other statutory compliances.
Manage regulatory submissions through CDSCO SUGAM, ONDLS, State FDA, DGFT, FoSCoS, ICEGATE, CBN, and other Government portals.
Liaise with CDSCO, State FDA, DGFT, Customs, CBN, Pollution Control Board, and other regulatory authorities.
Maintain the Corporate Compliance Calendar and monitor Licence validity, renewals, statutory approvals, and compliance status.
Develop and review compliance SOPs, statutory documentation, and internal compliance systems.
Coordinate with interdepartmental documentation requirement and its fulfillment.
Lead the compliance team, monitor KPIs, and prepare compliance dashboards and MIS reports.

Skills Required
Robust knowledge of the Drugs & Cosmetics Act & Rules, Revised Schedule M, WHO-GMP, CDSCO, and State FDA regulations.
Hands-on experience with Government licensing portals and statutory approvals.
Expertise in regulatory

📌 Sr Compliance And Licensing Executive Satara (India)
🏢 Nysa Biomed
📍 India