Regulatory Affairs Specialist

Responsibilities

1. Responsible and review of DCGI applications for BE-NOC, T-License and working standard Import license.
2. Responsible for query reply to all DCGI related matters like, BE-NOC, Import License and working standard Import license.
3. Responsible for feasibility of all molecules as per requirements of DCGI regulatory authority.
4. Responsible and review of DCGI Notification for IEC doc submission, Typo Error and minor /amendment changes application.
5. Responsible and Review of Test License Renewal Applications.
6. Responsible for quarterly filling of precursor molecule to NCB, Mumbai.
7. Responsible for submitting quarterly return of NDPS substances to CBN and state FDA.
8. Preparation and Review of DCGI Notification for not conducting study within six month from approval
9. Responsible for filling the Sponsor Questionnaire and Checklist.
10. Responsible for DCGI application for facility approval/renewal of application.
11. Responsible for DCGI requirement (feasibility of molecules)
12. Prepare, review and submit application on SUGAM & NSWS portals (BENOC, Test License, Protocol amendments, IEC notification etc.)
13. Handle regulatory submissions, query responses and approvals from DCGI, CDSCO (Central/Zonal), CBN, NCB and local FDA.

Share CVs on pradnya.raut@accutestglobal.com for faster reverts on you application.