Experience of Regulatory Information management [RIMS]
- System establishment & RIMS Implementation for Global Regulatory Information Management
- Maintenance of XEVMPD Submissions on EVWEB & on Register.
- Maintenance of the Registration portfolio(S)/Drug product.
- Co-coordinating with Global regulatory team for submissions and collating information to
maintain good data management for company.
- Co-coordinating with Pharmacovigilance team for timely PSUR submissions
- Prepare User Acceptance Testing report (UAT) with documentation.
- Keep registration track of the Products manufactured at Glenmark ( World- wide) at various plants LL,IH,TP
- Prepare Registration ...