Team Member - Reg. Assurance & Training

Job Purpose

Execute the regulatory assurance and training processes by maintaining RA documentation systems, tracking regulatory commitments and annual report submissions to achieve regulatory assurance for Cipla

Accountabilities

I. Check the regulatory commitments from Registration, Variations and Renewals till closure by continuous tracking and following defined procedures to achieve compliance to regulatory filings.
II. Check timely submission of Annual Report for all formulations and API registered with US market through defined procedures to meet compliance with US regulatory requirement.
III. Gather the impact of Import Alerts to registered API manufacturers and collate the impact assessment to ensure timely submission to CQA.
IV. Check timely submission of Biannual Report to Canada & annual report for South Korea DMF and WHO APIMF to meet compliance with regulatory requirement.

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