Senior Regulatory Affairs Specialist

Company Description NAPCO PHARMA is an Egyptian pharmaceutical company with a portfolio of more than 350 products spanning all major therapeutic areas. The company operates a state-of-the-art, GMP- and ISO-certified manufacturing facility in Egypt, emphasizing high quality and efficiency. NAPCO PHARMA exports its products to 15 countries across the Middle East and Africa, reflecting a strong regional presence and growth potential. The organization focuses on delivering the best quality at competitive prices, offering team members opportunities to contribute to accessible healthcare solutions.Role Description The Senior Regulatory Affairs Specialist is a full-time, on-site role based in Cairo, Egypt. This role is responsible for preparing, reviewing, and managing regulatory documentation to support product registrations, variations, renewals, and lifecycle management. The specialist coordinates regulatory submissions to local and international health authorities, ensuring alignment with current regulatory requirements, company policies, and industry standards. Daily tasks include monitoring regulatory changes, interpreting guidelines, advising internal stakeholders on compliance impacts, and maintaining accurate regulatory records and databases. The role also involves cross-functional collaboration with R&D, quality, and manufacturing teams to ensure timely approvals and ongoing regulatory compliance for existing and new products.QualificationsCandidates should possess strong skills in Regulatory Documentation and Regulatory Submissions to prepare, review, and file complete and accurate dossiers.Candidates should possess strong skills in Regulatory Compliance and Regulatory Requirements to interpret guidelines and ensure products meet all applicable standards.Candidates should possess solid expertise in Regulatory Affairs to manage interactions with health authorities and support strategic regulatory planning.Bachelor’s degree or higher in Pharmacy, Pharmaceutical Sciences, or a related scientific field.Several years of experience in regulatory affairs within the pharmaceutical industry, preferably with regional (Middle East and Africa) exposure.Thorough knowledge of GMP, quality systems, and relevant national and international regulatory frameworks.Strong analytical and problem-solving abilities, with attention to detail and accuracy in documentation.Effective communication and collaboration skills, with the ability to work cross-functionally and meet strict deadlines.Proficiency in English, with strong written and verbal communication skills; Arabic proficiency is an advantage.