Denis Thobias Mwangomo
DAR ES SALAAM,TANZANIA
Summary
Regulatory scientist and pharmaceutical regulatory affairs specialist with more than 10 years of experience in medicines regulation, dossier assessment, GMP inspections, quality management systems, risk management, regulatory harmonization and systems strengthening. Currently serves as Senior Drug Registration Officer at TMDA. Experienced in scientific assessment of APIs, FPPs, bioequivalence studies, herbal medicines and veterinary products. Participated in approximately 15 GMP inspections locally and internationally and contributed to TMDA's WHO Maturity Level 3 achievement.
Overview
13
13
years of professional experience
7
7
years of post-secondary education
Work history
Senior Drug Registration Officer
Tanzania Medicines and Medical Devices Authority
Dodoma, Tanzania
2013.12 - Current
- Assess quality requirements for human and veterinary medicines dossier files.
- Review herbal medicines dossiers against applicable regulatory expectations.
- Evaluate bioequivalence and biowaiver data to support safety and efficacy.
- Prepare technical assessment reports with clear recommendations for decision-makers.
- Participate in GMP inspections during audits of pharmaceutical manufacturing facilities.
- Implement WHO global benchmarking tool requirements across relevant evaluations.
- Support regulatory policy development and harmonisation initiatives with stakeholders.
- Mentor junior assessors and contribute to capacity-building programmes regularly.
External Consultancy
Global Health Insight, LLC
New Jersey, USA
2025.07 - 2025.12
- Develop templates and parameters for evidence-based briefs and Innovation Expo content
- Evidence reviews and documenting support for the second WHO TMGS
- Participation and contribution in the WHO TMGS & post-summit report
External Experty Dossier Assessor
Zambia Medicines Regulatory Authority
Lusaka, Zambia
2024.07 - 2025.06
- Evaluates quality of human medicinal dossier for API and FPP sections.
- Takes ownership of producing assessment reports following established regulatory review standards.
- Assessment of bioequivalence and Biowaiver data
- Leads preparation of quality assessment report for API and FPP submissions.
External consultant, 2301574
WHO - Global Traditional Medicine Centre
Jamnagar, India
2023.07 - 2023.12
- Develop the summit report with accurate technical content and clear structure.
- Compiled follow-up actions from the summit and facilitated stakeholder review to enhance project alignment.
- Coordinated design, scheduling, and delivery of summit technical sessions to ensure seamless execution.
Education
Master of Science - Biotechnology Innovation and Regulatory Science
Purdue university
Indiana, USA 2018.09 - 2020.06
Master of Science - Traditional medicines Development
Muhimbility University Of Health and Allied Science
Dar es Salaam, Tanzania 2010.10 - 2012.12
Bachelor of Education - Chemistry
University of Dar es Salaam
Dar es Salaam, Dar es Salaam Region 2006.09 - 2009.11
Skills
- Quality data (API & FPP) assessment
- Bioequivalence evaluation
- GMP compliance
- Regulatory system enhancement
- Report writing
- Risk-based decision making
Timeline
External Consultancy
Global Health Insight, LLC
2025.07 - 2025.12
External Experty Dossier Assessor
Zambia Medicines Regulatory Authority
2024.07 - 2025.06
External consultant, 2301574
WHO - Global Traditional Medicine Centre
2023.07 - 2023.12
Master of Science - Biotechnology Innovation and Regulatory Science
Purdue university
2018.09 - 2020.06
Senior Drug Registration Officer
Tanzania Medicines and Medical Devices Authority
2013.12 - Current
Master of Science - Traditional medicines Development
Muhimbility University Of Health and Allied Science
2010.10 - 2012.12
Bachelor of Education - Chemistry
University of Dar es Salaam
2006.09 - 2009.11