Romana Mtono
Dar Es Salaam
Summary
Detail-oriented and dynamic pharmaceutical professional with proven expertise in GMP compliance, regulatory science, and quality assurance across human and veterinary medicine sectors. Skilled in dossier evaluation, regulatory inspections, pharmacovigilance, and the implementation of quality management systems aligned with WHO, ICH, and TMDA standards. Experienced in clinical trial and bioequivalence (BE) assessments, import/export oversight, and post-market surveillance. Poised to lead robust quality frameworks in biopharmaceutical manufacturing and committed to advancing health equity through regulatory excellence in Africa.
Overview
5
5
years of professional experience
1
1
Certification
Work History
External Expert – Quality & Regulatory Compliance
Tanzania Medicines and Medical Devices Authority (TMDA)
Dar Es Salaam
12.2021 - Current
- Led evaluation of bioequivalence studies and clinical trial dossiers for drug approval, ensuring scientific validity and regulatory compliance.
- Reviewed regulatory submissions for human and veterinary pharmaceuticals to support market authorization decisions.
- Conducted GMP inspections of pharmaceutical production and distribution facilities to ensure alignment with regulatory standards.
- Participated in pharmacovigilance activities, including Annual Product Information Review (PIR), supporting data-driven decision-making.
- Contributed to national regulatory strengthening through workshops and technical review committees, supporting regulatory readiness and harmonization efforts.
Intern Pharmacist – Clinical QA Support
Muhimbili National Hospital (MNH)
Dar Es Salaam
07.2021 - 12.2021
- Carried out Adverse Drug Reaction (ADR) monitoring and reporting, contributing to hospital pharmacovigilance systems.
- Supported medication handling and documentation audits, ensuring alignment with national standards.
- Participated in ward rounds, ensuring safe medicine administration and counseling patients on therapy adherence.
- Dispensed medications to both inpatient and outpatient clients in accordance with hospital protocols and national treatment guidelines.
Intern Pharmacist – Regulatory & Inspection Unit
Tanzania Medicines and Medical Devices Authority (TMDA)
Dar Es Salaam
12.2020 - 06.2021
- Assisted in dossier assessments and data evaluation for product registration and safety monitoring.
- Supported quality audits and site inspections for regulatory compliance in storage and manufacturing facilities.
- Verified documentation integrity and assisted in tracking deviations during inspections and permit reviews.
- Prepared and processed import and export permits, ensuring pharmaceutical products and medical devices met documentation, safety, and traceability standards.
Education
Bachelor of Pharmacy (BPharm) - Pharmaceutical Sciences
Kampala International University – Tanzania
Dar Es Salaam09-2020
Skills
- GMP Compliance & Regulatory Inspection Preparedness
- Quality Management Systems (QMS) Implementation & Oversight
- Regulatory Submissions & Dossier Evaluation (BE, CTD, Clinical Trials)
- Pharmacovigilance & Post-Market Surveillance (PIR, ADR Reporting)
- Internal Quality Audits & SOP/Change Control Management
- Import/Export Permit Oversight & Market Access Compliance
- Technical Documentation Review & Data Integrity Assurance
- Cross-functional Collaboration with Regulatory, Clinical & Supply Chain Teams
Languages
Swahili
First Language
English
Proficient (C2)
C2
Certification
- Training in Medicine Evaluation & Registration – MTaPs/MSH-TMDA, 2021
- HIV/AIDS & TB Co-Inspection Training – Kibaha, 2021
- Good Pharmaceutical Practice (GPP) – Mwananyamala Referral Hospital, 2019
- Pharmaceutical Industry Field Work (GMP Exposure) – Kilimanjaro School of Pharmacy, 2019
- Pharmacovigilance & Product Lifecycle Management – Internal TMDA Programs, 2021–2022
References
Mr. Alex Juma Ismail
Regulatory Systems Strengthening Lead – AUDA NEPAD
📞 +255 718 541 327 | 📧 alexj@nepad.org
Richard Kulikiza Kasonogo
Drug Registration Officer – TMDA
📞 +255 713 414 823 | 📧 kasonogo@gmail.com
Rastony Prosper
Pharmacist – Mwanza Military Hospital
📞 +255 659 648 551 | 📧 mrastony07@gmail.com
Timeline
External Expert – Quality & Regulatory Compliance
Tanzania Medicines and Medical Devices Authority (TMDA)
12.2021 - Current
Intern Pharmacist – Clinical QA Support
Muhimbili National Hospital (MNH)
07.2021 - 12.2021
Intern Pharmacist – Regulatory & Inspection Unit
Tanzania Medicines and Medical Devices Authority (TMDA)
12.2020 - 06.2021
Bachelor of Pharmacy (BPharm) - Pharmaceutical Sciences
Kampala International University – Tanzania
Similar Profiles
Goodluck GotoraGoodluck Gotora
Clinical Trial and Pharmacovigilance Officer at Tanzania Medicines and Medical Devices Authority (TMDA)Clinical Trial and Pharmacovigilance Officer at Tanzania Medicines and Medical Devices Authority (TMDA)
Karim Ally MtengaiKarim Ally Mtengai
Senior Marketing Officer - Technical Personnel at Tanzania Biotech Products LimitedSenior Marketing Officer - Technical Personnel at Tanzania Biotech Products Limited
ACPA. Mathayo KibonaACPA. Mathayo Kibona
Senior Accountant at Tanzania Medicine and Medical Devices Authority (TMDA)Senior Accountant at Tanzania Medicine and Medical Devices Authority (TMDA)
Angela MbunaAngela Mbuna
Restaurant waiter at Four Recipes RestaurantRestaurant waiter at Four Recipes Restaurant
NATALY TONANATALY TONA
Grade 3 teacher at Sakana Primary schoolGrade 3 teacher at Sakana Primary school