Regulatory Affairs Executive

Vietnam, Ha Noi

In your role as Regulatory Affairs Executive, you will report to Regulatory Affairs Manager and your main responsibilities will be:

  • Prepare the registration dossier to comply with local regulation
  • Check and request additional document to Head Quarter
  • Submit the registration dossier and follow up with officers, experts to get the results in timely manner for assigned products
  • Coordinate with medical team to update PI for assigned products
  • Coordinate with person in charge of local content to get approval of drug label for assigned products and do checking labelling compliance
  • Coordinate with Supply Chain Manager to declare the registration price for  assigned products
  • Prepare and apply the application and necessary formalities to get the registration samples for assigned products