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.
