Nagireddy Basam

Executive - Drug Regulatory Affairs at Mylan Laboratories Limited (A Viatris Group)

Role
Executive - Drug Regulatory Affairs at Mylan
Location
Hyderabad, IN
LinkedIn followers
500 followers

About Nagireddy Basam

Member of team responsible for management of regulatory submissions for global markets:*Compilation of Drug master file for US, Europe & other ROW markets as per the current regulatory requirements.*Life cycle management of DMF annual reports, Amendments for US-FDA, Updations of Health CANADA and Revisions, Renewals for EDQM & Health care.*Filling ASMF\'s and DMF\'s for Europe, Australia and Canada market\'s based on Regulatory requirements.*Supporting with compilation of Deficiency responses for Regulatory Authorities as well as Customers.

Experience

  1. Executive - Drug Regulatory Affairs

    Mylan

    Oct 2020 — Present · Hyderabad, IN

Education

  • Sree Vidya Nikethan Institute of Management, A. Rangampet, Tirupati

    Msc - Organic Chemistry

    2011 — 2013

  • Sri Venkateswara Junior College, Lakkireddypalli

    Intermediate

    2005 — 2007

  • C.R Reddy Degree College, Rayachoty

    B.Sc

    2007 — 2010

  • ZPHS School, Devalam Palli.

    High School setion

    2000 — 2005

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Nagireddy Basam — Executive - Drug Regulatory Affairs at Mylan in Hyderabad, IN | Unifers