Technical Affairs Associate

Regulatory Affairs:

  • Downloading and saving of Regulatory transaction copies in respective folders as directed by Regulatory department.
  • Manage Regulatory inbox and save HC Communication in respective folder for each product
  • Monitor and update Regulatory tracker for new dossier – approved & submitted
  • Monitor and update Regulatory product information trackers for internal and external use
  • Monitor relevant technical affairs mailboxes daily
  • Coordinate with Supply chain to Track and updating Drug shortage website
  • Monitor, update and track following trackers:
    -Downloading and saving the convenience copy provided by the manufacturer in the AN supporting data folder
    -Saving the convenience copy in the respective product folder
    -Replacing the old CPID with new CPID
    -Monitor and update trackers with the current CPID Date & the changes implemented/product
    -Saving the current CPID in respective folders and replace with new CPID
  • PM Update/product:
    -Downloading and saving the PM provided by the manufacturer in respective folders
    -Downloading and saving the Pristine PM convenience copy and saving in respective product folder
    -Monitor and update tracker in Registered product information folder with Current date & Control#
    -Prepare email communication for website update on a monthly basis

Cross-license products:

  • Prepare, arrange, and provide all the provincial submission letter as per customer’s request
  • Review and provide cross-license documents to customers
  • Submitting confidential documents directly to formularies as per client request

Pharmacovigilance:

  • Increasing trend in number of products and associated activities related to RMP programs.
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