Firdous Basri

Experience

• 

  St. Martha's Hospital

  Jun 2016 - Jul 2016

  Intern
• 

  Manipal Hospitals

  Jan 2017 - Oct 2017

  Pharmacist
• 

  Adcock Ingram

  Oct 2017 - Jun 2019

  Compilation and preparation of a high quality CTD dossier and amendments as per specific countries requirement i.e South AfricaSupport the publication of high quality regulatory submissions to SAHPRA, Actively participate in development, review and process improvement activities.Compliance checking, bookmarking, QC/ review of documents, completion of Modules 1-5 in eCTD format and upload into docuBridge as per regulatory requirement.Working on Lorenz docuBridge – Upload of dossier as per eCTD format which includes getting the documents eCTD ready (OCR, bookmarking, PDF versioning).Preparation of quality responses to agency queries timeously suitable to be filed.Review of Drug Master File/CEP and all other relevant documentation according to SAHPRA/specific country requirements.Liaise aggressively with manufacturing site/customers/principals in order to get documents & timeously complete the product dossier.Documentation management according to internal organization practices. Interacting with various departments for collecting documents and reviewing the same as per the guidelines of specific country (where to be submitted) before compiling it to make dossier and handling timely follow up.Quality review of all of dossier as per current SAHPRA/specific country guidelines. Show less

  • Drug Regulatory Affairs officer

    Jan 2019 - Jun 2019

  • Regulatory affairs trainee officer

    Oct 2017 - Dec 2018
• 

  Parexel

  Jun 2019 - now

  • Senior Regulatory Affairs Associate

    Apr 2023 - now

  • Regulatory Affairs Associate

    Apr 2021 - Mar 2023

  • Junior Regulatory Affairs Associate

    Jun 2019 - Mar 2021