Werkervaringen, technieken

Apotex Research Private: Current Organization
Job Profile: Working as a Senior Associate in Regulatory Affairs Department [from June 2016 till date] at Apotex research Private Ltd, Bangalore. I am basically involved in the handling, Leading and eCTD Submission reviewing, publishing, and Validation of Dossier. My job profile is as follows:

  • Manage daily tasks associated with publishing regulatory submissions, including Bookmarking, hyperlinking and quality control of submission PDF files in accordance with FDA guidelines and other authorities.
  • Perform initial regulatory review of documents intended for publishing.
  • Good knowledge to work on eCTD submissions using soft wares (like Docubridge).
  • eCTD submission Review and validation for USA, Canada a as per the workload plan and also prioritize the low level submission for Australia and ROW market as per the requirements.
  • IMS (Regulatory Information Management System) and Track Wise.
  • Good communication skill and liaison with the cross functional team and various clients.
  • Execution and submission of the assigned projects well before the prescribed timelines.
  • Compilation, drafting and collation of Deficiencies for US (ANDAs), Australia and Canada

Cursussen, trainingen

BSC in Biochemisty

Diversen, hobbies

Traveling, reading novels, cycling

Wensen t.a.v. nieuwe functie

Pharmaceuticals, Biotechnology