Mai Thi Le

Regulatory Affairs Consultant

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.

Experience

  • Prepared and submitted drug registration dossiers to obtain marketing authorization for pharmaceutical products in Vietnam.
  • Prepared and submitted new registration and renewal dossiers for medical devices following the new regulation on management of medical devices in Vietnam.
  • Prepared new registration and renewal dossiers for medical devices to secure import licenses.
  • Converted global labeling for both drugs and medical devices to Vietnamese labeling to meet stringent requirements for Vietnam.
ABOUT Mai Thi

Industries

Life Sciences

Location

Languages

    Vietnamese

    English

Education

    Bachelor of Pharmacy, Hanoi University of Pharmacy

Insights

Awards & Rankings

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