Deputy Manager To Manager

7.0 - 10.0 years

10.0 - 14.0 Lacs P.A.

Ahmedabad

Posted:1 week ago| Platform: Naukri logo

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Skills Required

Regulatory Submissionsclinical trial documentation and complianceProficiency with Sugam Portal & NSWS PortalUnderstanding of Indian Regulatory Environment and GCP GuidelinesKnowledge of Forms CT-04

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities Job Description Deputy Manager/Manager DCGI Handling submissions in Sugam & NSWS Portal Preparation & Submission of 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 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

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