Industries
Life Sciences

Practices
Regulatory Affairs

Location
Vietnam

Languages
Vietnamese
English

Education

Bachelor of Pharmacy, Hanoi University of Pharmacy

Mai Thi Le
Regulatory Affairs Consultant
+84 24 3772 5607

Biography

Mai Thi Le is a regulatory affairs consultant at Tilleke & Gibbins. Based in the firm’s Hanoi office, she has a strong background in pharmaceuticals and medical devices. She holds a bachelor’s degree in pharmacy and has previous work experience at a global innovator life sciences company, where she handled regulatory affairs for medical devices, and a local pharmaceutical company, where she handled regulatory affairs for drugs.

Mai handles new, renewal, and variation applications for product registration and helps clients develop registration plans. She further assists by providing detailed information on the regulatory status of affected products and advice on appropriate regulatory processes, as well as other regulatory matters.


Experience
  • Prepared and submitted registration dossiers following relevant regulations in Vietnam for a wide range of products, including pharmaceuticals, medical devices, foods, cosmetics, insecticides, animal feed, and more.
  • Advised multiple clients in the life sciences sector on regulatory matters related to importation, manufacturing, and circulation of their products in Vietnam.
  • Advised a multinational pharmaceutical company for many years on drug promotion and non-promotional activities.
  • Regularly provide advice on regulatory compliance of products.
  • Converted global labeling for both drugs and medical devices to Vietnamese labeling to meet stringent requirements for Vietnam.