Regulatory Pharmacist โ Medirex Pharmaceuticals (Botswana) โ Apply by 13 June 2025
Job Opportunity: Regulatory Pharmacist โ Medirex Pharmaceuticals (Botswana) โ Apply by 13 June 2025
Location: Gaborone, Botswana
Position: Regulatory Pharmacist
Company: Medirex Pharmaceuticals
Contract Type: Full-Time
Closing Date: 13 June 2025
Overview:
Medirex Pharmaceuticals is seeking a qualified and experienced Regulatory Pharmacist to oversee and manage the companyโs regulatory compliance processes. The ideal candidate will have an in-depth understanding of medicine safety, efficacy, and qualityโparticularly within the framework of Botswanaโs pharmaceutical regulations. This role is crucial in ensuring that all products meet the necessary legal standards and regulatory requirements of BOMRA.
Key Responsibilities:
-Manage day-to-day operations of pharmaceutical distribution in compliance with regulatory standards.
-Oversee departmental budgeting and monitor expenditure.
-Coordinate and prepare for regulatory inspections.
-Ensure full compliance with Botswana Medicines Regulatory Authority (BOMRA) requirements.
-Review and assess major and minor product variations.
-Receive, evaluate, and file dossiers for new product registrations and variations.
-Provide expert advice on regulatory strategies and processes for medicine registration.
-Evaluate the quality, safety, and bioequivalence of pharmaceuticals, particularly generic medicines.
-Advise senior management on policy, compliance, and new product development.
-Deliver internal training sessions on regulatory submissions and dossier assessments.
-Maintain strict adherence to all applicable regulatory laws and procedures.
Requirements:
-Bachelor of Pharmacy (Honours) degree
-Must be registered with the Botswana Health Professional Council (BHPC)
-Minimum of 3 years regulatory experience
-Prior experience working with a Medicines Regulatory Authority is essential
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