QUALITY ASSURANCE & REGULATORY AFFAIRS ASSISTANT

KEY RESPONSIBILITIES

Regulatory Affairs

• Support preparation, compilation and review of CTD/eCTD and country-specific registration dossiers.
• Collect and coordinate regulatory documents from manufacturers, including GMP, CPP, FSC, manufacturing licences, DMF/CEP, CoA, specifications and stability data.
• Support new product registrations, renewals, variations and regulatory submissions.
• Maintain regulatory trackers for submissions, approvals, renewals and variations.
• Follow up on regulatory authority queries, deficiency letters and pending documents.
• Coordinate with local agents, consultants and regulatory authorities when required.
• Monitor registration timelines and ensure timely submission of documents.
• Support regulatory research for new African and MENA markets.

Quality Assurance

• Maintain and organize product quality and compliance documentation.
• Review documents for completeness, consistency and compliance with requirements.
• Support collection and review of CoAs, specifications, GMP certificates, licences, stability data and other quality documents.
• Coordinate with manufacturers on quality documentation and outstanding requirements.
• Support QA documentation, supplier/manufacturer qualification and audit-related activities.
• Maintain controlled records, trackers and QA/RA databases.
• Support preparation and follow-up of quality complaints, deviations, CAPA and other QA activities, as applicable.

Coordination & Administration

• Maintain accurate electronic and physical QA/RA records.
• Prepare document checklists and follow up with manufacturers and internal teams.
• Coordinate with Business Development, Procurement, Supply Chain and Finance teams.
• Ensure all regulatory and quality documents are properly filed and readily available.
• Support multiple products, countries and deadlines simultaneously.
• 2–5 years of experience in Regulatory Affairs, Quality Assurance or pharmaceutical documentation.
• Experience in pharmaceuticals and/or medical devices preferred.
• Practical exposure to Africa and/or MENA regulatory requirements is highly preferred.
• Basic understanding of CTD/eCTD, product registration, renewals and variations.
• Good understanding of GMP and pharmaceutical quality documentation.
• Strong document management and attention to detail.
• Good follow-up, coordination and communication skills.
• Proficient in MS Office/Excel and document management systems.
• Fluent English required; French is an advantage.
• Ability to work independently and manage multiple priorities.