Tabassum Sirajam Munira

Tabassum Sirajam Munira is an accomplished pharmaceutical quality and regulatory professional with over 22 years of experience spanning laboratory accreditation, capacity building, and international quality management frameworks. Currently she serves as the Pharmaceutical Quality & Regulatory Affairs Specialist at TRACE Consulting. Over her distinguished career, she has built a reputation for driving institutional readiness, designing state-of-the-art laboratory infrastructures, and strengthening national regulatory systems to align with rigorous worldwide standards.

Working closely with public health institutions, national regulatory authorities, and international donor-funded programs, Tabassum has consistently translated complex global compliance guidelines into robust, scalable quality ecosystems. Her deep expertise covers international laboratory standards (including ISO/IEC 17025 and ISO 15189), WHO prequalification, data integrity, and cross-border regulatory frameworks.

She served as the technical advisor for QA/QC under the USAID-funded PQM+ Program (led by USP). In this pivotal role, she provided strategic technical leadership to elevate the analytical capabilities and quality frameworks of Bangladesh’s apex testing facilities, including the National Drug Control Laboratory (NDCL), the Drug Control Laboratory in Chattogram (CDTL), and the Institute of Epidemiology, Disease Control, and Research (IEDCR).

Under her technical guidance, the project achieved landmark international milestones, including securing ISO/IEC 17025 accreditations (via BAB and ANAB), obtaining WHO prequalification for the NDCL’s physicochemical and microbiology wings, and supporting the DGDA in achieving WHO GBT ML-3 accreditation preparedness for vaccines. Additionally, she spearheaded the design of the modernized CDTL laboratory layout, established specialized medical device and COVID-19 vaccine testing facilities, and co-authored crucial national guidelines for vaccine lot release, emergency use authorizations, and risk-based post-marketing surveillance.

Earlier in her career, Tabassum spent over a decade as the Head of Analytical Method Development at Eskayef Pharmaceuticals Ltd. In this capacity, she directed a high-performing team of 30 professionals in analytical validation and stability studies, while successfully leading laboratory readiness for stringent global inspections, including MHRA, TGA, and USFDA audits.

Beyond her project and corporate leadership, Tabassum is a recognized regional expert and educator. She has represented Bangladesh in the SEARN regional network, conducted international manufacturing and laboratory audits across South Asia, and regularly delivers specialized capacity-building training to regulatory inspectors, government analysts, and university students.

She holds a Bachelor of Pharmacy (B.Pharm) and a Master of Pharmacy (M.Pharm) from Jahangirnagar University, alongside a Master of Public Health (MPH) specializing in health promotion and health education from the Bangladesh University of Health Sciences.