Manager CQA Licensing

Meyer Organics; Mumbai; On-site; INR 600,000 - 800,000; Full time

Job summary

Meyer Organics in Mumbai seeks a regulatory professional to prepare and file approvals for licenses and registrations (PRP, TL, NCC, MMC, FSC, COPP, Neutral code, plan layout changes, wholesale license, GLP, GMP, RP, CP) and coordinate visits to FDA, FSSAI and CDSCO offices to expedite approvals.

You will manage annual returns, license renewals, changes, and special codes; prepare label claims, SOIs, and compliance reports; support audits, tender registrations, and regulatory notices with timely

Responsibilities

• Prepare and file approvals for licenses and registrations (PRP, TL, NCC, MMC, FSC, COPP, Neutral code, plan layout changes, fresh wholesale license, GLP, GMP, RP, CP) and coordinate visits to FDA, FSSAI and CDSCO offices to expedit e approvals.
• Prepare and submit annual returns, license modifications, and renewals (FSSAI license) and handle fresh license applications.
• Prepare and apply for Special Neutral Code, test license, and test license NOC to CDSCO.
• Prepare label claims and SOIs for license applications and review supporting documents.
• Support during FDA and FSSAI audits and assist in preparing compliance reports.
• Provide cross-departmental support to Tender, Export, and Registration departments for licenses and product registrations.
• Respond to legal matters and notices from regulatory bodies.
• Submit and track cough syrup sample submissions to CDTL lab and follow up on test reports.
• Monitor license validity and provide required documents to stakeholders.
• Arrange working/reference standards, COAs, and product specifications from relevant locations for market sampled products.
• Review analytical tax invoices and clearances as required.
• Any other duties assigned by the head of department.

Job description

1. To prepare and take approvals for applications like PRP, TL, NCC, MMC, FSC, COPP, Neutral code, Plan layout modifications, fresh wholesale license, GLP, GMP, RP, CP for own site. Visit to FDA, FSSAI and CDSCO offices for expediting the same.
2. To prepare and submit annual returns, Modification, update in license, fresh license application, and renewal of FSSAI license.
3. To prepare and apply for Special Neutral Code, test license, and test license NOC to CDSCO.
4. Label claim and SOI preparation for license application. Review of supporting documents while applying for license.
5. Support during FDA and FSSAI audits and support during preparation compliance reports.
6. Cross-Departmental Support: To provide requested license to Tender department (To participate in Tender), Export department (for customs clearance), and Registration departments (for product registration purposes).
7. Responding to legal matters and Notice from regulatory bodies.
8. To submit and track Cough syrup sample to CDTL lab and timely follow up with them for test reports.
9. To keep track on license validity and provide required documents to stakeholders
10. Arrange working/reference standards, COAs, and specifications from the relevant location for market sampled products.
11. Analytical tax invoice review and clearance.
12. Any other job assigned by the head of department, as per work requirements.