
Regulatory Affairs Specialist
4 days ago
Senior Manager Regulatory Affairs
- 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
- Familiarity with regulatory affairs
- Excellent communication skills
- Ability to work in a team
- Prominent role in the company
- Opportunities for growth and development
Local candidate preferred from Ahmedabad
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