Senior Manager Regulatory Affairs

0 years

0 Lacs

Posted:1 month ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Role :


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


[Note: Local Candidate required from Ahmedabad ]

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Cadila Pharmaceuticals Limited logo
Cadila Pharmaceuticals Limited

Pharmaceuticals

Ahmedabad

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