REGULATORY AFFAIRS SPECIALIST – AFRICA & MENA

KEY RESPONSIBILITIES

• Develop regulatory strategies and manage product registrations, renewals and variations across Africa and MENA.
• Prepare, review and coordinate CTD/eCTD and country-specific regulatory dossiers.
• Coordinate with manufacturers to obtain and review required documents, including GMP, CPP, FSC, DMF/CEP, CoA, specifications, stability data and manufacturing licences.
• Manage regulatory submissions, authority queries, deficiency letters and responses through to approval.
• Maintain an updated regulatory tracker covering submissions, approvals, renewals, variations and regulatory commitments.
• Liaise with National Regulatory Authorities, local agents and regulatory consultants.
• Support product selection and new market expansion by providing regulatory feasibility and requirements.
• Monitor regulatory changes in Africa and MENA and advise relevant internal teams.
• Work closely with QA, Business Development, Procurement and manufacturers to ensure timely and compliant submissions.
• Ensure regulatory documentation is properly maintained and activities are completed within agreed timelines.
• 5–10+ years of Regulatory Affairs experience in pharmaceuticals and/or medical devices.
• Proven hands-on experience with Africa and MENA regulatory submissions and registrations.
• Good knowledge of Francophone and/or Anglophone African markets.
• Strong experience in CTD/eCTD dossiers, renewals, variations and regulatory queries.
• Good understanding of GMP and pharmaceutical regulatory documentation.
• Experience coordinating with manufacturers, regulatory authorities, agents and consultants.
• Strong attention to detail, organisational and project-management skills.
• Ability to manage multiple countries, products and deadlines independently.
• Fluent English required; French is highly desirable.
• Willingness to travel internationally when required.