Senior Regulatory Specialist - Pharmacist
Atco Pharma
Company Description Atco Pharma is a well-established pharmaceutical company specializing in both human and veterinary healthcare products and is ranked among the leading industry players in Egypt. The company manufactures its products according to Good Manufacturing Practice (GMP) standards, ensuring high levels of safety and reliability for patients. Atco Pharma also follows ISO standards and was awarded the International Quality Crown Award in 2015 for its commitment to quality and excellence. Guided by a strong understanding of the value of health and well-being, the company focuses on developing therapeutic solutions that reflect these principles. Role Description The Senior Regulatory 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 human and veterinary pharmaceutical products in line with local and international requirements. The role includes maintaining up-to-date knowledge of relevant regulations, guidelines, and standards, and ensuring product registration, variations, renewals, and labeling comply with regulatory expectations. The specialist collaborates with cross-functional teams such as R&D, quality assurance, production, and marketing to provide regulatory input throughout the product lifecycle. Daily activities also involve managing regulatory documentation, responding to authority queries, supporting audits and inspections, and contributing to continuous improvement of regulatory processes. Qualifications Strong regulatory affairs expertise, including experience with product registration, variations, renewals, and labeling in the pharmaceutical sector. Solid knowledge of GMP, ISO standards, and relevant national and international regulatory guidelines for human and veterinary medicines. Professional background as a licensed Pharmacist, with a Bachelor’s degree in Pharmacy or a closely related field; advanced certifications in regulatory affairs are an advantage. Proficiency in preparing, organizing, and reviewing technical documentation, dossiers, and regulatory submissions with high attention to detail. Effective communication and collaboration skills for working with multidisciplinary teams and interacting with regulatory authorities. Strong analytical, problem-solving, and time-management abilities, with capacity to handle multiple projects and deadlines. Good command of English and Arabic, both written and spoken; strong computer and documentation management skills. Previous experience in a similar senior regulatory role within a pharmaceutical company is highly desirable. Show more
