Senior Regulatory Affairs Specialist

Job DescriptionPrepare, compile, and submit registration dossiers for new products (human medicines, medical devices, or cosmetics as applicable) to the health authorities.Handle product renewals, variations, and post-approval changes according to regulatory timelines.Ensure regulatory compliance of product labeling, artwork, and promotional materials.Maintain up-to-date knowledge of local and international regulations, guidelines, and procedures (e.g. Egyptian Drug Authority – EDA, SFDA, EMA, FDA).Communicate with health authorities to follow up on submission status and respond to queries in a timely manner.Coordinate with internal departments (Quality, R&D, Supply Chain, Marketing) to gather required documentation and information.Maintain and update regulatory databases, registration trackers, and product files.Support audits and inspections by providing regulatory documentation as needed.Train junior team members and provide technical guidance where required.Participate in regulatory strategy discussions for new products and business opportunities.Job Requirements• A bachelor's degree in Pharmaceutical Science is a common requirement.• Typically, 3-6 years of relevant experience in a regulatory affairs role within the pharmaceutical industry, with proven experience in local registration processes.• Fluent in both written and spoken English and Arabic.• Excellent communication, negotiation, time management, and organizational skills.• Detail-oriented, a proactive problem-solver, with the ability to manage multiple projects and work effectively in cross-functional teams.