0 years
0 Lacs
Posted:1 month ago|
Platform:
On-site
Full Time
Job Description:
Handling submissions in Sugam & NSWS Portal
Preparation & Submission of o New Drug applications, Subsequent New Drug Applications
Clinical trial application - Phase I, II, III, IV (Form CT-04)
BA/BE Export application (Form CT-05)
Test License application (Form CT-10, Form CT-13, Form CT-14, Form CT-16, Form-11)
Manufacturing new drug & Marketing (MA) application (Form CT-21)
Import new drug & Marketing application (Form CT-18)
Form-40 & Form-10 application
Post approval changes
RCGM Submission o for R&D activities o Pre-clinical toxicity study of vaccines (Form C-1, Form C-3b)
Dual use NOC application
Import and export application of Narcotic & Psychotropic substance
Submission of Quarterly returns to CBN, Gwalior
Cadila Pharmaceuticals Limited
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