Executive- Regulatory Affairs
6 days ago
Role & responsibilities
Responsible for CDSCO, DCGI, state FDA work compliances
Coordination with CDSCO to get clarity on few of our products whether they are under new drug or old drug.
Preparation and online submission of BA/BE NOC application to CDSCO.
Preparation and online submission of CT-10 for manufacturing the new drug (Indore & Bhiwadi).
Preparation and online submission of CT-16 & Form 12 for import of new & old drug.
Prepare application for COPP NOC for Indore site and Bhiwadi site.
Response the queries to DCGI for the application (BE/BA NOC, Form CT-10, Form CT-16 & Form 12, COPP NOC.
Preparation of application for renewal of certificate (WHO-GMP, manufacturing license, wholesale license, FSSAI, DSIR).
COPP's for all countries, Product permission (domestic & export), FSC, Form 29, export NOC, Shelf life extension of products.
Preferred candidate profile
Understanding of FD&C Act and experience of Liaoning with CDSCO and State FDA.
Experience of applying Form 29, Form 12, CT-05, CT-10, CT-16 and other applications/licenses.
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