RA Senior Specialist - Pharmacist

Company Description Atco Pharma is a well-established pharmaceutical company serving both human and veterinary healthcare, consistently ranked among the leading providers in Egypt. The company manufactures its products according to Good Manufacturing Practice (GMP) standards, ensuring high levels of safety and reliability for patients and customers. Atco Pharma also adheres to ISO standards and received the International Quality Crown Award in 2015, recognizing its strong commitment to quality and excellence. Guided by a deep understanding of health and well-being, the organization is dedicated to developing therapeutic solutions that deliver meaningful value to healthcare professionals and patients alike. Role Description The RA Senior Specialist - Pharmacist is a full-time, on-site role based in Cairo, Egypt. This position is responsible for preparing, reviewing, and submitting regulatory dossiers for new and existing pharmaceutical products in line with local and international requirements. The role involves maintaining up-to-date knowledge of regulatory guidelines, coordinating with internal departments (such as production, quality, and marketing), and ensuring product labeling, packaging, and documentation comply with applicable standards. The RA Senior Specialist will monitor regulatory timelines, follow up on approvals, support audits and inspections, and contribute to lifecycle management activities such as variations and renewals. The individual will also provide regulatory input to cross-functional projects, helping to align product development and market strategies with compliance obligations. Qualifications Solid regulatory affairs expertise in pharmaceutical products, including dossier preparation, submission, and follow-up with health authorities. Strong knowledge of GMP, ISO standards, and relevant national and international regulatory guidelines. Proficiency in technical documentation, with attention to detail in reviewing product labeling, artwork, and promotional materials for compliance. Effective communication and collaboration skills for working with cross-functional teams such as quality, production, R&D, and marketing. Excellent organizational and time-management skills, with the ability to handle multiple projects and meet regulatory deadlines. Bachelor’s degree in Pharmacy; a postgraduate degree or certification in Regulatory Affairs or a related field is an advantage. Previous experience in regulatory affairs within the pharmaceutical industry, preferably in Egypt or the MENA region. Strong command of English and Arabic, both written and spoken, and confident use of standard office and documentation software. Show more Show less