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)
🏢 Nysa Biomed
📍 Satara