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
BSC in Biochemisty
Traveling, reading novels, cycling
Wensen t.a.v. nieuwe functie