REGULATORY AFFAIRS SPECIALIST – AFRICA & MENA

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.