DOSSIER ASSESSOR – BoMRA

VACANCY

BoMRA

The Botswana Medicines Regulatory Authority (BoMRA) is a dynamic, fast-paced organization committed to the regulation of human and veterinary medicines, medical devices, complementary medicines & cosmetics. We are driven by our values of integrity, excellence, team spirit, transparency, and innovation. We operate in a collegial environment that encourages collaboration and professional excellence. Joining BoMRA means being part of a team that prioritizes continuous learning and a positive impact on public health. We are looking for enthusiastic individuals to join us in the following areas:

DOSSIER ASSESSOR (X3)

JOB PURPOSE:

The Dossier Assessor is responsible for evaluating applications for medicine registration, ensuring that all authorized medicines meet legal and regulatory requirements in Botswana concerning their quality, safety, and efficacy.

KEY RESPONSIBILITIES

– Assist in the evaluation of dossiers for human, veterinary, and complementary medicines to ensure compliance with regulatory standards.
– Design, plan, and implement processes, standards, and guidelines for the registration of medicines.
– Conduct administrative and technical assessments of registration applications, review variations and renewals.
– Provide advice to external stakeholders on regulatory matters, interpretation of regulatory requirements, and acceptability of data submitted in registration applications.
– Work closely with the Manager and Head of the Evaluation and Registration Department to ensure that all approved products in the market meet registration requirements.
– Prepare and review technical documents, reports, and committee submissions for regulatory decision-making.
– Process applications for exemptions from registration of medicine and certificates for further investigation.
– Contribute to policy development and assessment outcomes and assist in providing technical feedback on regulatory decisions to applicants.
– Maintain up-to-date knowledge of medicines registration and regulatory databases.
– Assist in updating and maintaining standard operating procedures (SOPs), templates, and regulatory guidance documents.
– Engage and educate stakeholders on medicine registration requirements and processes.

QUALIFICATIONS & EXPERIENCE (APPLICABLE TO BOTH ROLES):

– Bachelor’s degree in pharmacy, veterinary Science, Biomedical sciences, Pharmaceutical Sciences, Nursing Science, Pharmacology, Toxicology, Pharmaceutical sciences or any related field from a recognized institution.
– At least three (3) years of relevant work 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 (APPLICABLE TO BOTH ROLES)

– Regulatory & Compliance Awareness: Understanding of pharmaceutical regulations, drug safety, and market authorization.
– Analytical & Problem-Solving Skills: Ability to evaluate complex scientific data, assess risks, and develop sound regulatory outcomes.
– Attention to Detail: Ability to review and analyze technical reports, regulatory dossiers, and inspection findings with accuracy.
– Communication & Stakeholder Engagement: Strong verbal and written communication skills, with the ability to engage industry stakeholders, healthcare professionals, and regulators.
– Time Management & Report Preparation: Ability to draft clear, well-structured, and comprehensive reports on regulatory documents.
– Teamwork & Learning Agility: Ability to collaborate effectively with teams while continuously developing knowledge in regulatory science and compliance frameworks.
– Integrity & Professionalism: High ethical standards, reliability, and ability to handle confidential regulatory matters responsibly.