Regulatory Affairs (new drug, medical device)

• Acting with business pioneer team to set up the business and team in Vientiane
• Responsible for product registration and life cycle maintenance.
• Supporting all necessary regulatory information to related function for solving the problems.
• Support and participate in GMDP, GDP, ISO 13485, ISO 140001 and other standard requirements of company.
• Prepares, submits, coordinates and follows up on product registration according to product registration plan.
• Coordinates, reviews and aligns the artworks of all packaging materials.
• Renew all regulatory licenses