Officer- Corporate Quality Assurance (Licensing)

Rubicon Research; Thane; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Rubicon Research seeks a Regulatory Affairs professional to manage licensing and compliance across State FDA, CDSCO, and NDPS/NOC processes. The role involves preparing applications, coordinating inspections, and maintaining statutory records.

The candidate will liaise with regulators to ensure timely approvals, and travel to Rubicon sites for audits and audits-related support as required.

Qualifications

• Bachelor of Pharmacy or Master of Science.
• Experience in state and national licensing requirements.

Responsibilities

• Obtain, renew, amend, and maintain State FDA licenses.
• Prepare and submit Form 25/28 Manufacturing License; Form 29 Test License for Examination Test, Analysis and Bioequivalence Study.
• Coordinate approvals for addition/deletion of products, blocks, dosage forms, and technical staff.
• Liaise with State FDA officials for inspections, approvals, and regulatory compliance.
• Prepare, submit, and track CDSCO applications (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.
• Coordinate applications and renewals related to NDPS licensing (Import/Export Certificates, Import NOC).
• Maintain statutory records and documentation under NDPS Act and Rules.
• Coordinate annual quota applications, utilization reports, and regulatory inspections by CBN.
• Maintain centralized repository of licenses, import/export/test licenses, NOCs, COPPs, government correspondence, and inspection reports.
• Ensure licenses remain valid and renewals/amendments are submitted before expiry.
• Serve as primary regulatory liaison with State FDA, CDSCO, CBN, WHO, and other authorities; coordinate inspections and document submissions.

Education

Bachelor of Pharmacy / Master of Science

Job description

Role & responsibilities:

• 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 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

Preferred candidate profile:

Bachelor of Pharmacy / Master of Science

Experience in state and national licensing requirements

Additional notes:

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