Vishnunand Singh Yadav

Regulatory Affairs Executive @Lupin Pharmaceuticals

IN

Tracking all changes time to time and update in the Annual Report of all approved products and ensure submissions of all changes to FDA and other regulatory market Ensure to track and report all changes in the annual report (e.g, API notification for AR related changes captured in the annual report) Submissions of supplements and Annual report as per FDA current requirement. Review of revised BMR, BPR, Specification and stability protocol. Change control evaluate and approve as per regulatory guidelines. Compilation of the supplements in guidance of Manager i.e, PAS, CBE 30, and CBE to ensure compliance with FDA. Query response of ROW market.

BBD University

B.pharm ( BBDU Lucknow)