Regulatory Affairs

Department: Regulatory Affairs

Experience: 3 years to 6 years

JOB RESPONSIBILITIES

1. Preparation, review and planning of submission of CTD/ACTD/ECTD for export market.
2. Floating of official email for technical documents and queries reply.
3. Prepare/monitoring site registration documents for export market.
4. Registration/Re-registration/post approval changes application for export market.
5. Resolve the technical query related to product registration/Re-registration/post approval changes.
6. Follow-up and coordination with internal stake holder ( QA, QC, R&D, Technical services
7. Department, production, packing, account, purchase & business development).
8. Review of technical documents, Process validation, Stability data, Analytical method validation,
9. Product development report, finished product specification, Qualitative Quantitative formula
10. Standard testing procedure, batch manufacturing record, batch packing record, certificate of
11. Analysis, container and closure system and open part Drug master file.
12. To intimate & review of BE study from Approved BE center.
13. Follow-up with manufacturing site for register sample, working standard & impurity requirement for lab analysis.
14. To prepare monthly regulatory status report and status of new registration/Re-registration/post approval changes.
15. Coordination with stakeholder for collecting documents for preparation of dossier, review of
16. dossier and submission to respective regulatory authority.
17. Review of artwork and pack insert as per rules laid by respective regulatory authority.
18. Preparation and submission of Product safety update report.
19. Coordinate the renewal of FDA license (GMP, COPP, manufacturing license, wholesale).