Company Description NAPCO PHARMA (National Company for Pharmaceutical Industries) is an established Egyptian pharmaceutical company with a portfolio of more than 350 products covering all major therapeutic areas. The company operates a state-of-the-art manufacturing facility in Egypt that is GMP and ISO certified, reflecting a strong commitment to quality and compliance. NAPCO PHARMA exports its products to 15 countries across the Middle East and Africa, offering broad regional exposure. The company focuses on delivering high-quality medicines at competitive prices, providing value to both healthcare providers and patients. Joining NAPCO PHARMA offers the opportunity to contribute to a growing, quality-driven organization with an international footprint.
Role Description The Senior Regulatory Specialist is a full-time, on-site role based in New Cairo. The role is responsible for preparing, reviewing, and submitting regulatory dossiers and documentation to local and international health authorities, ensuring timely approvals and renewals. The Senior Regulatory Specialist will monitor and interpret regulatory requirements, maintain up-to-date product registration files, and support compliance with GMP, ISO, and other relevant standards. Daily tasks include coordinating with cross-functional teams (such as QA, QC, production, and marketing), responding to regulatory inquiries, and supporting product variations and lifecycle management. The role also involves participating in audits and inspections, contributing to regulatory strategy for new products, and training internal stakeholders on regulatory guidelines and changes.
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