Officer

Rubicon Research Limited; Thane; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Rubicon Research Limited in Thane, Mumbai is seeking an Officer to manage statutory licensing activities across State FDA, CDSCO, CBN, WHO and other authorities to support uninterrupted manufacturing and export operations.

The role covers license procurement, renewal, amendment, and maintenance, as well as coordinating audits, documents, and inspections, with travel across Rubicon sites as required.

Qualifications

• Bachelor of Pharmacy or MSc required.
• Experience with licensing processes and regulatory submissions appreciated.
• Willingness to travel across Rubicon sites for audits and regulatory support.

Responsibilities

• Manage State FDA licensing including procurement, renewal, amendment and maintenance.
• Prepare and submit Form 25/28 for Manufacturing Licenses and Form 29 for Test Licenses.
• Coordinate licensing approvals with CDSCO including Form 11, CT-17, CT-11/CT-14 and Export/NDPS licenses.
• Coordinate WHO-GMP licensing via ONDLS portal; obtain COPP and renewal certificates.
• Coordinate Central Bureau of Narcotics licensing; handle NDPS import/export authorizations.
• Maintain centralized license documentation and ensure renewals before expiry.
• Liaise with regulatory authorities for inspections and timely approvals.
• Ensure compliance and timely responses to deficiency letters and queries.

Skills

Regulatory liaison

Documentation

Attention to detail

Education

Bachelor of Pharmacy / Master of Science

Job description

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

Sr 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
• WHO-GMP Licensing
  • Prepare, submit, and track applications through the ONDLS Portal
  • Prepare and obtain:
    • COPP (Certificate of Pharmaceutical Products)
    • Renewal WHO-GMP Certificates
• 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 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