Company Description NAPCO PHARMA (National Company for Pharmaceutical Industries) is an Egyptian pharmaceutical manufacturer with a portfolio of more than 350 products covering a broad range of therapeutic areas. The company operates a state-of-the-art manufacturing facility in Egypt that is GMP and ISO certified, ensuring high-quality standards. NAPCO PHARMA exports its products to 15 countries across the Middle East and Africa, reflecting its strong regional presence and growth potential. The organization is committed to delivering high-quality medicines at competitive prices, providing meaningful opportunities for professionals seeking to contribute to accessible healthcare.
Role Description The Senior Regulatory Affairs Specialist is a full-time, on-site role based in New Cairo. The specialist is responsible for preparing, reviewing, and managing regulatory documentation for new and existing pharmaceutical products, ensuring alignment with local and international regulatory requirements. Day-to-day tasks include coordinating regulatory submissions, maintaining product registrations, monitoring regulatory changes, and supporting cross-functional teams in compliance matters. The role also involves interacting with health authorities, responding to regulatory queries, and contributing to regulatory strategy to support product launches and lifecycle management. The specialist will collaborate closely with quality, manufacturing, and R&D teams to ensure timely and accurate regulatory deliverables.
Qualifications
- Candidates should possess strong skills in Regulatory Affairs and a solid understanding of Regulatory Requirements.
- Candidates should possess experience in Regulatory Documentation and Regulatory Submissions.
- Candidates should possess expertise in Regulatory Compliance, including familiarity with GMP and relevant local and international guidelines.
- Bachelor’s degree or higher in Pharmacy, Pharmaceutical Sciences, or a related field.
- Several years of experience in regulatory affairs within the pharmaceutical industry, preferably in a manufacturing environment.
- Strong attention to detail, analytical skills, and ability to interpret regulatory guidelines and laws.
- Effective communication and collaboration skills, with the ability to work cross-functionally and manage multiple projects.
- Proficiency in documentation management and MS Office; experience with regulatory information systems is an advantage.
- Fluency in English and Arabic, both written and spoken, is highly beneficial.