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 & Healthcare
- 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 / 3731727
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 are the typical qualifications and educational background required for a Dossier Assessor at a regulatory authority in Botswana?
Candidates typically need a Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related medical/health science field. Postgraduate qualifications or specialized training in regulatory affairs or quality assurance are often highly advantageous for this role in Botswana.
What are the common day-to-day responsibilities of a Dossier Assessor for medical products in Botswana?
Daily tasks involve meticulously reviewing scientific and technical documentation (dossiers) submitted for product registration against Botswana's specific regulatory guidelines. This includes preparing detailed assessment reports, communicating findings to applicants, and ensuring all submissions comply with local medicine regulations.
What is the typical work culture and expectations for a professional role like Dossier Assessor within a regulatory body in Botswana?
The work culture emphasizes professionalism, strict adherence to established procedures, and a high degree of accuracy and attention to detail. You'll be expected to be diligent, collaborate effectively with colleagues, and uphold ethical standards crucial for public health protection in Botswana.
What are the realistic career progression and growth paths for a Dossier Assessor within the regulatory sector in Botswana?
Career progression often involves moving into senior assessor roles, specializing in specific product categories, or taking on supervisory positions within the authority. Further professional development in regulatory affairs or quality management can also open doors to leadership or expert consultant roles within the industry.
What typical benefits, such as leave, medical aid, and pension, can a Dossier Assessor expect from a regulatory authority in Botswana?
As a role within a parastatal body, common benefits typically include competitive annual leave, sick leave, and maternity leave provisions in line with Botswana labour laws. Most employers also offer comprehensive medical aid schemes and contributions to an employee pension fund.
How should I best prepare my application, and what do employers in Botswana specifically look for in a Dossier Assessor candidate?
Your application should feature a clear, concise CV highlighting relevant scientific or regulatory experience and a cover letter detailing your analytical skills and understanding of regulatory frameworks. Employers seek candidates who demonstrate meticulousness, strong technical knowledge, and excellent communication abilities.