
Chief Regulatory Compliance Officer
4 days ago
This is a senior-level position responsible for handling submissions in various portals, preparing and submitting new drug applications, clinical trial applications, and other regulatory documents. The ideal candidate should have experience in regulatory affairs, strong communication skills, and the ability to work independently.
Key Responsibilities:
- 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
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