SR. compliance and licensing Executive

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

• Strong 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 admin documentation for dossiers, government liaison, and compliance management.
• Strong documentation, communication, leadership, and project management skills.
• Proficiency in MS Office and ERP systems.