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 applicat

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