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Cadila Pharmaceuticals
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Deputy Manager To Manager

Deputy Manager To Manager

Cadila Pharmaceuticals

7 - 10 years

10 - 14 Lacs

Ahmedabad

Posted:2 months ago| Platform:

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Skills Required

Regulatory Submissions clinical trial documentation and compliance Proficiency with Sugam Portal & NSWS Portal Understanding of Indian Regulatory Environment and GCP Guidelines Knowledge 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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Deputy Manager To Manager