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 medicine to ensure compliance with regulatory standards.
• Develop, review, and implement processes, standards, and guidelines for the registration of medicines.
• Conduct administrative and technical assessments of applications for pre-marketing authorization, post-registration variations, and renewals.
• 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 all approved products in the market meet regulatory requirements.
• Prepare and review technical documents, reports, and committee submissions for regulatory decision-making.
• Process applications for exemptions from registration of medical 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 and educate stakeholders on medicine registration requirements and processes.

QUALIFICATIONS & EXPERIENCE (APPLICABLE TO BOTH ROLES)

• Bachelor’s degree in pharmacy, Veterinary Science, Biomedical Sciences, Biological 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 solutions.
• 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.
• Technical Writing & Report Preparation: Ability to draft clear, well structured, and comprehensive reports and regulatory documents.
• Teamwork & Learning Agility: Ability to collaborate effectively with teams while continuously developing knowledge of regulatory science and compliance frameworks.
• Integrity & Professionalism: High ethical standards, reliability, and ability to handle confidential regulatory matters responsibly.

APPLICATION INSTRUCTIONS:
If you are ready to be part of an organization that values career growth, submit your application, including your latest CV, certified copies of qualifications, and contact details for two referees, to: recruitment@bomra.co.bw.

For inquiries contact: HR Office on 3731906/3731727

Address for applications:
The Chief Executive Officer
Botswana Medicines Regulatory Authority
P. Bag 02, Gaborone

Closing Date for Submission:
07 March 2025. Only shortlisted candidates will be contacted