Dossier Assessor (x2 Positions) – Botswana Medicines Regulatory Authority

Job Description

VACANCY: DOSSIER ASSESSOR (X2)

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

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.

QUALIFICATIONS & EXPERIENCE
• 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.

KEY COMPETENCIES
• 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.

APPLICATION INSTRUCTIONS
Submit the following to [email protected]:
• Latest CV
• Certified copies of qualifications
• Contact details for two referees

Closing Date: 29 July 2025.

Only shortlisted candidates will be contacted.