SR. compliance and licensing Executive

Nysa Biomed; Satara; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Nysa Biomed in Satara, Maharashtra seeks Head Compliance & Licensing to lead pharmaceutical licensing, statutory compliance, government liaison, inspections, and regulatory approvals in line with Drugs & Cosmetics Act and related regulations. Ensure timely licences, renewals, and inspection readiness across operations.

Note: Product registrations and country-specific regulatory submissions are managed by the Regulatory Affairs Department.

Qualifications

• Experience in managing licensing and compliance under Drugs & Cosmetics Act.
• Strong knowledge of regulatory authorities and government portals.
• Experience with licensing renewals and inspections.

Responsibilities

• Manage WHO-GMP, GMP, COPP, FSC, Manufacturing, License renewals and amendments.
• Handle regulatory compliances with CDSCO, State FDA, DGFT, FSSAI, MPCB/CPCB, Fire NOC and other acts.
• Coordinate regulatory submissions through CDSCO SUGAM, ONDLS, State FDA, DGFT, FoSCoS, ICEGATE and others.
• Liaise with CDSCO, State FDA, DGFT, Customs, Pollution Control Board and other authorities.
• Maintain Compliance Calendar, renewals, approvals, and status tracking.
• Develop and review compliance SOPs and internal documentation.
• Coordinate interdepartmental documentation needs and fulfillment.
• Lead the compliance team and prepare dashboards and MIS reports.

Skills

Regulatory Compliance

Regulatory Submissions

Documentation

Leadership

MS Office

Education

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

Tools

CDSCO portals

SUGAM

FoSCoS

ERP systems

Job description

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

• 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.