Function: Regulatory Affairs
Job Location: Halol and Dadra
Experience: 4-10 years
Brief Job Description:
1) Monitoring for Documents compilation activities for New product filing, Re-Registration/renewals from plant 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.
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