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Jr. Regulatory Affairs Office (African Registration and Pharmacovigilance Representation) at Droga Pharma PLC
Position Title: Jr. Regulatory Affairs Office (African Registration and Pharmacovigilance Representation)
Employer: Droga Pharma PLC
Employment: Full-Time | Permanent
Place of Work: Addis Ababa - Ethiopia
Posted date: 5 days ago
Deadline: December, 31/2025 (2 days left)
Job Summary
We are looking for a qualified professional to manage regulatory affairs, product registration, and dossier preparation across African markets, ensure compliance with EFDA and country-specific requirements, oversee pharmacovigilance activities including safety monitoring and adverse event reporting, act as the primary liaison with EFDA, support QMS implementation, and provide regulatory updates and training to ensure efficient and compliant regulatory operations.
Main Duties & Responsibilities
African Registration
- Support the registration of Droga’s products across African countries in line with the company’s regulatory roadmap.
- Research and understand the regulatory frameworks of respective African countries.
- Create accounts with national regulatory authorities and establish communication channels with Local Technical Representatives (LTRs) and regulators.
- Prepare, compile, and submit regulatory dossiers and documentation to the relevant authorities.
- Follow up on product registration processes until approval is granted.
- Assist in establishing Quality Management Systems (QMS) and fulfilling regulatory requirements for wholesale or import operations in selected African countries.
- Monitor and proactively engage with African harmonization initiatives to leverage opportunities for streamlined registration.
- Provide regular awareness sessions and updates to the Regulatory Affairs (RA) team and management on country-specific regulatory developments.
- Perform any other duties assigned to ensure smooth regulatory operations across African countries.
Pharmacovigilance
- Monitor the safety, quality, and efficacy of marketed products and compile reports for submission to EFDA.
- Act as the single point of contact with EFDA on pharmacovigilance matters, including inspections.
- Ensure adverse drug event reporting systems are available, accessible, and understood by health professionals.
- Collect, process, evaluate, and forward adverse event reports to EFDA within stipulated timelines.
- Prepare and submit pharmacovigilance documents in compliance with Directive 932/2022.
- Maintain proper documentation and archival of pharmacovigilance records.
- Provide pharmacovigilance training to staff and participate in continuous professional development.
- Conduct pharmacovigilance self-audits and ensure data quality in submissions.
- Monitor emerging safety concerns and oversee the safety profiles of marketed products.
- Review local and international journals for published adverse events and report relevant findings to EFDA.
Dossier Development
- Prepare regulatory dossiers for products intended to be manufactured by the company’s sites, in line with EFDA and African country requirements.
- Collaborate with senior RA officers to ensure dossiers meet regulatory standards and are submission-ready.
- Compile and organize technical, clinical, and administrative data required for dossier preparation.
- Ensure timely submission of dossiers to regulatory authorities as per company plans.
- Maintain records of dossier development activities and regulatory correspondence.
- Support continuous improvement in dossier preparation processes.
- Assist in responding to authority queries regarding dossier content and compliance.
Qualification
- Educational Background: Bachelor’s degree in Pharmacy.
- Experience: No prior experience required (entry-level).
- Language: Fluency in English, French, and at least one local language.
Additional Skills
- Ability to understand and interpret regulatory guidelines and requirements.
- Excellent communication and interpersonal skills for liaising with authorities and stakeholders.
- Proficiency in preparing, reviewing, and submitting regulatory documentation.
- Aware of African Medicines Regulatory Harmonization (AMRH) initiatives and continental regulatory trends.
- Ability to work independently and collaboratively in a multicultural environment.
- Strong understanding of pharmacovigilance principles and regulatory dossier preparation.
- Ability to analyze safety data and prepare reports.
- Good communication skills for liaising with health professionals and regulatory authorities.
- Ability to work collaboratively with senior RA officers and cross-functional teams.
How to apply
Interested applicants can use our email
hr@drogapharma.com
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