Regulatory Affairs Assistant - (contract temporary 1 year)

• Bachelor’s degree, preferred
• Knowledge in Regulatory Affairs on healthcare products.
• Can work independently as well as in a team with relevant departments in Vietnam.
• Ability to read, analyze, and interpret governmental regulations and reports.
• Must be able to effectively operate in a PC environment, be familiar with Microsoft Word, Excel, PowerPoint, Access, Outlook and Internet data search utilities.

• Social insurance
• 15 annual days

Activities will include regulatory compliance and regulatory submissions.

• Timely compile and prepare regulatory documentation for submission of Medical Devices, Food Supplements and Cosmetics to local authorities.  This includes new product registration submission, variation to registered products, license renewal, etc.
• Co-ordinate, validate labeling, direction for use and user manuals for the country for regulatory compliance.
• Monitor advertising/promotional materials developed in Vietnam for compliance with product claims.
• Maintain updated RA databases of registered products and documentation to ensure information is accurate and up to date.
• Support RA/QA manager in formulation of regulatory projects and keep abreast of local regulation, guidance and standards applicable to URGO’s products.
• Ensure updates of proper documentation as requested by Sales/Maketing/Logistics and provide administrative support in terms of Regulatory Affairs to relevant departments.