Title: Sr Manager - RA
1 |
Monitoring for Documents compilation activities for New product filing, Re-Registration/renewals from plant for dossier filing, sample requirements etc. |
2 |
Participation in Action plan discussion for queries from different Regulatory agencies and monitoring for submission of data/documents from plant . |
3 |
Coordination with CRA, ADD, FDD, MSTG ,PMO ,Plant team and with other CFT Members for regulatory requirements related to Registration, Re-Registration, queries, and variation filing. |
4 |
Product Life Cycle Management: Active participation in Change control committee meeting. – Discussion with different Stakeholders and decision for final variation category (After taking concurrence from CRA, Country RA and Customers if require). |
5 |
Activities related to Variation management - Tracking of Variation filing, approvals and intimation to plant for implementation of changes. |
6 |
Support plant for business continuity of products by filing variations wherever applicable. |
7 |
Monitoring for circulation of Regulatory Approvals and commitment details to Plant Team for US and OAM and Approval package for emerging market. |
8 |
Participation in all launch discussions with plant CFT , business team , CRA to identify gap & mitigation plan. |
9 |
Circulation of Regulatory strategies and Guidelines, wherever applicable |
10 |
Support plant during Regulatory Inspections. |
11 |
Monitoring for Product permissions, test licences and lay out archival activities for Local FDA . |