NYSABioMed
Website:
nysabiomed.com
Job details:
Company Description Nysa Biomed (India), part of NYSA BIO MED PVT LTD, operates a new state-of-the-art manufacturing plant in Satara, Maharashtra, focused on pharmaceutical formulations, finished products, OTC items, and nutraceutical medicines. The company offers large-scale third-party contract manufacturing at competitive prices, along with loan license facilities for partner organizations. Nysa Biomed is committed to improving global patient health through innovative products developed in collaboration with researchers, health authorities, and patients. The organization emphasizes integrity, quality, and unity, supported by robust quality systems and advanced technology for sustained-release products. Employees are encouraged to work with purpose and passion to deliver timely, high-quality medicines that support the welfare of society.
Role Description The Compliance & Licensing Executive is a full-time, on-site role based at the Satara manufacturing facility. This position is responsible for managing all licensing activities, including obtaining, renewing, and maintaining statutory approvals and regulatory permits for pharmaceutical and nutraceutical products. The role involves monitoring compliance with relevant laws and guidelines, maintaining accurate documentation and records, and coordinating with regulatory bodies, internal quality teams, and external partners. The Executive will review contracts and agreements related to third-party manufacturing and loan license arrangements, support audits and inspections, and provide compliance-related guidance to internal stakeholders. Daily activities include preparing reports, tracking deadlines, supporting internal training on compliance requirements, and assisting in risk assessment and mitigation.
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.
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