Regulatory Affairs - AM/DM | Vaccine/Biotech Industry

Desired Experience : 7 to 15 years

Job Location : Genome Valley, Shameerpet, Hyderabad

Preferred Industry : Vaccines/ Biotech

Main purpose of the Job:

Responsible for Preparation and Review of Regulatory Documents for submission to Indian NRA, WHO and other Regulatory Authorities.

Job Responsibilities:

1. Preparation and Review of following Regulatory Submission Packages related to NRA submissions but not limited to.

a. Form-29 NOC applications

b. Clinical Trial Applications

c. Marketing Authorization Applications

d. Application for Post Approval Change(s)

e. Preparation and submission of Import licenses/ export NoC

f. Preparation, review and submission of applications/ response to RCGM vide IBSC

g. Handling of SUGAM, IBKP, NSWS & ONDLS/ ODLS sites

2. Response to Queries from NRA.

3. Preparation of required documents for WHO submissions.

4. Preparation of dossiers for registration in ROW countries.

5. Maintenance of Documentation Data base available with RA.

6. Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution and Marketing.

7. Routine Interaction with QA-documentation for updating Master Files.

8. Review of Pack Profiles.

9. Review of Artworks (Labels and Package Insert).

10. Tracking and Regulatory Assessment for New compendia.

11. Preparation / compilation of technical documents related to tenders / queries.

12. Arranging Samples required for registration.

13. Any other support required by the other members of RA.