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 Title-Officer

Department-Corporate Quality Assurance (CQA)

Reporting To-Assistant Manager CQA

Location-Thane, Mumbai

Years of Experience 1 – 3 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:
Form 25& 28 – Manufacturing License
Form 29 – Test License for Examination Test & Analysis and Bioequivalence Study
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
CDSCO Licensing
Prepare, submit, and track applications through the CDSCO SUGAM Portal
Coordinate statutory approvals including:
Form 11 & CT-17 – Import License
CT-11 / CT-14 – Test License NOC
Export NOC
Dual Use NOC
Coordinate responses to CDSCO deficiency letters and regulatory queries
Liaise with CDSCO officials and consultants to obtain approvals within defined timelines
CBN (Central Bureau of Narcotics) Licensing
Coordinate applications and renewals related to NDPS
Prepare and obtain:
Import Certificate for NDPS materials
Export Authorization for NDPS products
Import NOC
Maintain statutory records and documentation required under the NDPS Act and Rules
Coordinate annual quota applications, utilization reports, and regulatory inspections by CBN
Documentation & Compliance Management
Maintain a centralized repository of:
Manufacturing Licenses
Import Licenses
Test L

📌 Officer (Thane)
🏢 Rubicon Research
📍 Thane