About the Job
Droga Pharma PLC is seeking a motivated and detail-oriented professional to support regulatory affairs, product registration, dossier preparation, and pharmacovigilance activities across African markets. The role ensures compliance with EFDA and country-specific regulatory requirements while supporting quality systems and regulatory operations.
🔹 Key Duties & Responsibilities
African Product Registration
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Support registration of Droga Pharma products across African countries in line with the regulatory roadmap
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Research and understand regulatory frameworks of respective African markets
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Create accounts with national regulatory authorities and coordinate with Local Technical Representatives (LTRs)
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Prepare, compile, and submit regulatory dossiers and documentation
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Follow up on registration processes until approval is granted
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Support Quality Management System (QMS) setup for wholesale/import operations
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Monitor African Medicines Regulatory Harmonization (AMRH) initiatives
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Provide regular regulatory updates and awareness sessions to management and RA teams
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Perform other regulatory tasks assigned to ensure smooth operations
Pharmacovigilance
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Monitor safety, quality, and efficacy of marketed products
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Act as the primary liaison with EFDA on pharmacovigilance matters
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Ensure adverse drug event reporting systems are functional and understood
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Collect, process, evaluate, and submit adverse event reports within timelines
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Prepare pharmacovigilance documents in line with Directive 932/2022
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Maintain accurate pharmacovigilance records and archives
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Conduct self-audits and ensure data quality
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Monitor emerging safety concerns and published adverse event literature
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Provide pharmacovigilance training and continuous professional development
Dossier Development
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Prepare regulatory dossiers for locally manufactured products
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Compile technical, clinical, and administrative documentation
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Support submission readiness and respond to authority queries
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Maintain records of dossier activities and correspondence
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Support continuous improvement of dossier preparation processes
👤 About You
Competency Requirements
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Education: Bachelor’s Degree in Pharmacy
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Experience: No prior experience required (entry-level)
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Language: Fluency in English, French, and at least one local language
Additional Skills
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Ability to interpret regulatory guidelines
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Strong communication and stakeholder coordination skills
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Proficiency in regulatory documentation preparation
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Understanding of African regulatory environments and AMRH initiatives
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Strong pharmacovigilance knowledge
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Ability to analyze safety data and prepare reports
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Team-oriented with strong attention to detail
🧠Requirement Skill
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Attention to detail
📬 How To Apply
Interested applicants are invited to apply via email:
📧 hr@drogapharma.com
