Purpose-Responsible for ensuring regulatory compliance through effective management of statutory licensing activities, including procurement, renewal, amendment, and maintenance of licenses and approvals from State FDA, CDSCO, CBN, WHO, and other regulatory authorities to support uninterrupted manufacturing and export operations.
Position / Job TitleSr. Officer
DepartmentCorporate Quality Assurance (CQA)
Reporting ToAssistant Manager CQA
LocationThane, Mumbai
Years of Experience 3 - 5 Years
Dosage Form-All applicable dosage forms (Oral solid, Nasal, Liquid oral, Topical, Injectable)
Job Responsibilities / Deliverables
- State FDA Licensing
- Obtain, renew, amend, and maintain manufacturing licenses issued by the State Food & Drug Administration (FDA)
- Prepare and submit applications for:
- Public Testing Laboratories
- Layout Approval Modification
- Free Sale Certificate
- ND-I Possession License
- Form 20B & 21B Wholesale License
- Technical Staff Approval
- Poison License
- Neutral Code Approval
- Trasport Permits for Narcotic Drugs
- Form 20G for Schedule X Drugs
- Form 25A Loan License
- Coordinate approvals for addition/deletion of products, manufacturing blocks, dosage forms, and technical staff.
- Liaise with State FDA officials for inspections, approvals, and regulatory compliance
- Maintain compliance with the Drugs and Cosmetics Act, 1940 and Rules, 1945
- Coordination with CMO's for regulatory compliance
- WHO-GMP Licensing
- Prepare, submit, and track applications through the ONDLS Portal
- Prepare and obtain:
- COPP (Certificate of Pharmaceutical Products)
- Renewal WHO-GMP Certificates
- Maintain compliance with the WHO requirements.
- NCB (Narcotics Control Bureau) Licensing
- Coordinate applications and renewals related to Controlled Substances
- Prepare and obtain Form A Registration Certificate
- Reconciliation & Quarterly Return Submission in Form F
- Maintain statutory records and documentation required under the NDPS Act and Rules
- CBN (Central Bureau of Narcotics) Licensing
- Coordinate applications and renewals related to NDPS-controlled substances
- Prepare and obtain Quota Allocation & renewal for Narcotic Drugs
- Import Export Endorsement
- Reconciliation & Quarterly Return Submission
- Maintain statutory records and documentation required under the NDPS Act and Rules
- Overview of Domestic Business Regulatory Compliance
- Coordinate DPCO Consultant for compliance verification.
- Monitor Form II, III & V filings, Downward price revision implementation, NPPA notice response process &
- Manage domestic regulatory approvals with respect to new formulation
- CDSCO Licensing
- Prepare, submit, and track applications through the CDSCO SUGAM Portal & ONDLS Portal
- Coordinate responses to CDSCO deficiency letters and regulatory queries
- Liaise with CDSCO officials and consultants to obtain approvals within defined timelines
- Documentation & Compliance Management
- Maintain a centralized repository of:
- Manufacturing Licenses
- Import Licenses
- Test Licenses
- Export NOCs
- Dual Use NOCs
- NDPS Import/Export Authorizations
- COPPs
- Government correspondence
- Inspection reports
- Ensure all licenses remain valid and applications for renewal or amendments are submitted well before expiry
- Regulatory Liaison
- Serve as the primary point of contact with State FDA, CDSCO, CBN, WHO certification authorities, and other statutory bodies
- Coordinate inspections, meetings, and submission of regulatory documents.
- Follow up on pending applications to ensure timely approvals
Qualifications & Pre-Requisites
Bachelor of Pharmacy / Master of Science
Additional Notes
Experience in state and national licensing requirements
It would require travelling across Rubicon sites for local FDA audit support during the various regulatory / customer audits at manufacturing sites. Also, had to travel to local FDA and CDSCO offices as per requirement
