VACANCY
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BoMRA
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\nThe 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:
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\nDOSSIER ASSESSOR (X3)
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\nJOB PURPOSE:
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\nThe 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.
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\nKEY RESPONSIBILITIES
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\n\u2013 Assist in the evaluation of dossiers for human, veterinary, and complementary medicines to ensure compliance with regulatory standards.
\n\u2013 Design, plan, and implement processes, standards, and guidelines for the registration of medicines.
\n\u2013 Conduct administrative and technical assessments of registration applications, review variations and renewals.
\n\u2013 Provide advice to external stakeholders on regulatory matters, interpretation of regulatory requirements, and acceptability of data submitted in registration applications.
\n\u2013 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.
\n\u2013 Prepare and review technical documents, reports, and committee submissions for regulatory decision-making.
\n\u2013 Process applications for exemptions from registration of medicine and certificates for further investigation.
\n\u2013 Contribute to policy development and assessment outcomes and assist in providing technical feedback on regulatory decisions to applicants.
\n\u2013 Maintain up-to-date knowledge of medicines registration and regulatory databases.
\n\u2013 Assist in updating and maintaining standard operating procedures (SOPs), templates, and regulatory guidance documents.
\n\u2013 Engage and educate stakeholders on medicine registration requirements and processes.
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\nQUALIFICATIONS & EXPERIENCE (APPLICABLE TO BOTH ROLES):
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\n\u2013 Bachelor\u2019s degree in pharmacy, veterinary Science, Biomedical sciences, Pharmaceutical Sciences, Nursing Science, Pharmacology, Toxicology, Pharmaceutical sciences or any related field from a recognized institution.
\n\u2013 At least three (3) years of relevant work experience in the pharmaceutical sector, regulatory affairs, government, or a national\/ international NGO.
\n\u2013 Strong knowledge of pharmaceutical regulatory frameworks, medicine safety, and compliance.
\n\u2013 Familiarity with Good Manufacturing Practices (GMP), pharmacovigilance, dossier evaluation, and medicine licensing requirements.
\n\u2013 Proficiency in ICT applications for regulatory assessment, reporting, and database management.
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\nKEY COMPETENCIES (APPLICABLE TO BOTH ROLES)
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\n\u2013 Regulatory & Compliance Awareness: Understanding of pharmaceutical regulations, drug safety, and market authorization.
\n\u2013 Analytical & Problem-Solving Skills: Ability to evaluate complex scientific data, assess risks, and develop sound regulatory outcomes.
\n\u2013 Attention to Detail: Ability to review and analyze technical reports, regulatory dossiers, and inspection findings with accuracy.
\n\u2013 Communication & Stakeholder Engagement: Strong verbal and written communication skills, with the ability to engage industry stakeholders, healthcare professionals, and regulators.
\n\u2013 Time Management & Report Preparation: Ability to draft clear, well-structured, and comprehensive reports on regulatory documents.
\n\u2013 Teamwork & Learning Agility: Ability to collaborate effectively with teams while continuously developing knowledge in regulatory science and compliance frameworks.
\n\u2013 Integrity & Professionalism: High ethical standards, reliability, and ability to handle confidential regulatory matters responsibly.
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JOB APPLICATION DETAILS<\/p>\n
APPLICATION DETAILS
\nAPPLICATION INSTRUCTIONS:
\nInterested candidates can send their organization that creates growth submit your application, including your latest CV, certified copies of qualifications, and contact details for two referees, to: recruitment@bomra.co.bw.<\/p>\n
For inquiries contact: HR Office on 3713906\/3731727<\/p>\n
Address for applications:
\nThe Chief Executive Officer
\nBotswana Medicines Regulatory Authority
\nP. Bag 00493
\nGaborone<\/p>\n
Closing Date for Submission:
\n13th September 2025. Only shortlisted candidates will be contacted.<\/p>\n
Plot 112, International Finance Park, Gaborone
\nPrivate Bag 2, Gaborone Station, Botswana
\n+267 373 1727\/30 Toll Free: (0800) 600 218<\/p>\n
info@bomra.co.bw
\nBotswana Medicines Regulatory Authority
\nwww.bomra.co.bw<\/p>\n
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