Regulatory Affairs Assistant

Mô tả Công việc
RESPONSIBILITIES
1. Support all RA processes to ensure compliance:
Support Product Notification process for NPL (New product launch) & EPL (Exist product launch) by :
o Check ingredients to ensure the compliance of formula.
o Prepare dossiers for notification submission & obtain notification approval and filing the Master Notification file.
o Collect data from Regone/PDS and share to agency for notification preparation & submission.
o Follow up closely with Drug Administration Vietnam (DAV) to update status of submitted notification.
o Update final name on CFS to master file.
o Request CFS & LOA for products.
o Check all data of products in RegOne /PDS/RDS systems and upload data to Regone systems.
o Manage product data in system, processing file, master file,...
Support Advertising License process:
o Prepare all advertising documents & submit to Department of Health HCM (DOH HCM).
o Follow up with DOH HCM to update status of submission.
Support Vietnamese labelling:
o Check & update new Vietnamese labelling to master file.
o Request APAC to create new content labelling (if any).
2. Administration tasks:
o Proceed payment to DAV and agency.
o Follow up with those Authority to collect invoices.
3. Other tasks: as assigned by line manager.