Senior Manager Regulatory Affairs

Role : Senior Manager Regulatory Affairs

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 ]