JOB PURPOSE
The Dossier Assessor is responsible for evaluating applications for the registration and authorization of human medicines, veterinary medicines, complementary medicines, and regulated cosmetic products, ensuring that products placed on the Botswana market comply with applicable legal and regulatory requirements relating to quality, safety, efficacy (where applicable), and cosmetic safety and compliance
Job Summary
- Type: full-time
- Location: Gaborone
- Category: Medical & Pharmaceutical
- Closing Date: 2026-07-29
Key Responsibilities
- Assist in the evaluation of dossiers for human, veterinary, complementary medicines, and cosmetic products to ensure compliance with applicable regulatory requirements
- Develop, review, and implement processes, standards, guidelines, and technical requirements for the registration, listing, and authorization of medicines and cosmetic products.
- Conduct administrative and technical assessments of applications for pre-market authorization, post-registration variations, renewals, and cosmetic notifications/listings where applicable.
- Prepare detailed technical assessment reports on the acceptability of data submitted in registration applications.
- Work closely with the Manager and Head of the Evaluation and Registration Department to ensure that approved and authorized products on the market continue to meet regulatory requirements.
- Prepare and review technical documents, reports, and committee submissions for regulatory decision-making.
- Process applications for exemptions from registration of regulated products.
- Ensure timely communication of assessment outcomes and regulatory decisions to applicants.
- Maintain up-to-date medicine registers and regulatory databases.
- Assist in updating and maintaining Standard Operating Procedures (SOPs), templates, and regulatory guidance documents.
- Engage, educate, and provide regulatory guidance on medicines and cosmetic product requirements.
- Contribute to continuous improvement initiatives by monitoring international regulatory developments and recommending enhancements to regulatory practices.
Requirements
- Bachelor’s degree in pharmacy, Medicine, Pharmacology, Toxicology, Pharmaceutical Sciences, or a related field from a recognized institution.
- Applicants from non-pharmacy disciplines should demonstrate relevant experience or training in medicines
- At least three (3) years’ relevant experience in the pharmaceutical sector, regulatory affairs, government, or a national/international NGO.
- Strong knowledge of pharmaceutical regulatory frameworks, medicine safety, and compliance.
- Familiarity with Good Manufacturing Practices (GMP), pharmacovigilance, dossier evaluation, and medicine licensing requirements.
- Proficiency in ICT applications for regulatory assessment, reporting, and database management.
- Regulatory & Compliance Awareness – Understanding of pharmaceutical regulations, medicine safety, and market authorization.
- Analytical & Problem-Solving Skills – Ability to evaluate complex scientific data, assess risks, and develop solutions.
- Attention to Detail – Ability to review and analyze technical reports, regulatory dossiers, and inspection findings accurately.
- Communication & Stakeholder Engagement – Strong verbal and written communication skills with the ability to engage industry stakeholders, healthcare professionals, and regulators.
- Technical Writing & Report Preparation – Ability to draft clear, structured, and comprehensive reports and regulatory documents.
- Teamwork & Learning Agility – Ability to collaborate effectively while continuously developing regulatory science and compliance knowledge.
- Integrity & Professionalism – High ethical standards, reliability, and ability to handle confidential regulatory matters responsibly.
How to Apply
Phone: 3731906
Address: Plot 112, International Finance Park, Gaborone
About the Company
The Botswana Medicines Regulatory Authority (BoMRA) is a statutory body established under the Medicines and Related Substances Act of 2013, operating exclusively within Botswana. Its primary mandate is to protect public health by ensuring the safety, efficacy, and quality of medicines, medical devices, cosmetics, and other health products available in the country. BoMRA plays a critical role in regulating the importation, manufacture, distribution, and sale of these products across Botswana. By upholding stringent standards and promoting judicious use, the Authority contributes significantly to a healthier nation and a robust healthcare system in Gaborone and beyond.
Protecting public health through regulation of medicines and medical devices.
Frequently Asked Questions
What qualifications and experience are typically required for a Dossier Assessor role in Botswana?
Candidates generally need a Bachelor's degree in Pharmacy, Pharmacology, Chemistry, or a related health science field. Relevant experience in regulatory affairs, quality assurance, or pharmaceutical manufacturing is highly advantageous. A postgraduate qualification can also strengthen an application.
What are the common day-to-day responsibilities of a Dossier Assessor at the Botswana Medicines Regulatory Authority?
You would primarily evaluate complex scientific dossiers for medicinal products to ensure their quality, safety, and efficacy comply with national and international standards. This involves meticulous review of data and preparing detailed assessment reports for regulatory decisions.
What is the typical work culture like at a regulatory body in Botswana, and what are the career progression opportunities for a Dossier Assessor?
The work culture emphasizes professionalism, meticulous attention to detail, and adherence to strict regulatory guidelines, often involving collaborative team efforts. Career progression can lead to senior assessor roles, specialization in specific product categories, or moving into regulatory policy development within the Authority.
What kind of benefits package can a Dossier Assessor expect from a public regulatory body in Botswana?
Employees typically receive competitive benefits including annual leave, sick leave, and contributions to a medical aid scheme. A pension fund contribution is also a common part of the overall compensation package for such professional roles in Botswana.
What do employers in Botswana look for in a successful application for a Dossier Assessor position, and what is the typical application process?
Employers seek strong analytical skills, exceptional attention to detail, a solid understanding of pharmaceutical regulations, and excellent written communication. The application process usually involves submitting a detailed CV and cover letter, followed by interviews and potentially a technical assessment.