Vivekanand Kamble

Experience

• 

  Shree Anand Life Sciences LTD.

  Sept 2016 - Apr 2017

  Jr.Executive Production

  Key Roles: Handling of Autoclaves with respect to GMP & Maintained SOP with compliance of GDP.

• 

  Parexel

  Aug 2017 - now

  >Experience in working on different types of submissions like US, EU, Swiss, Canada, Australia, GCC and ROW regions.>Perform various Post Publishing activities like external linking, Publishing (Paper, Nees, eCTD) QC and Validation (using various tools like ISI Toolbox, Smart desk, eCTD express, Docubridge, Lorenz) of submissions and fixing any issues encountered during the process.>Involved in dispatch of submissions to various agencies (ESG gateway US and Canada, EMA) & Preparing CD labels for gulf region. Show less

  • Senior Regulatory Affairs Associate

    Mar 2022 - now

  • Regulatory Affairs Associate, CORE

    Jan 2020 - Mar 2022

  • Jr. Associate Regulatory Publisher

    Aug 2017 - Dec 2019