Dr. Sonia Sebai is the Head of the National Control Laboratory at Tunisia’s National Regulatory Authority, a position she has held since 2023. With over a decade of expertise in pharmacology, pharmaco-toxicology, and regulatory science, she has played a key role in strengthening Tunisia’s regulatory framework for medicines and vaccines.

She currently serves as head of evaluation of CMC dossiers for chemical, biological, biosimilar, and vaccine products, and has led the Pharmaco-Toxicology Department at the National Drug Control Laboratory. She has been instrumental in guideline development, notably as the redactor of the new Tunisian Guidelines for the Registration of Medicinal Products through reliance procedures (2025) and as a contributor to the country’s first biosimilar guidelines (2018).

At the regional and international level, she is a member of the North African Medicines Regulatory Harmonization (NA-MRH) Secretariat and Working Group, as well as a member of the WHO Expert Committee on Biological Standardization. She contributed to the WHO CMC assessment of COVID-19 vaccines during the pandemic and has conducted GMP audits of biological manufacturing sites abroad. Nationally, she serves on several scientific committees, including the COVID-19 Vaccine Scientific Committee and the National Biosimilar Pharmaco-Toxicology Committee.

Her academic credentials include recognition as a Senior Specialist in Pharmacology by Tunisia’s Ministry of Health, certification as a Certified Professional in Healthcare Quality (CPHQ) by the NAHQ in Chicago, and advanced training in Leadership, Management, and Implementation Science in Global Health at the University of Washington. Earlier in her career, she gained international experience in Saudi Arabia as a Clinical Pharmacologist, Drug Information Center Supervisor, and Quality Consultant in the hospital pharmacy certification program.