Job Description · Handling submissions in Sugam & NSWS Portal · Preparation & Submission of o New Drug applications, Subsequent New Drug Applications o Clinical trial application - Phase I, II, III, IV (Form CT-04) o BA/BE Export application (Form CT-05) o Test License application (Form CT-10, Form CT-13, Form CT-14, Form CT-16, Form-11) o Manufacturing new drug & Marketing (MA) application (Form CT-21) o Import new drug & Marketing application (Form CT-18) o 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
