Registration Section Head

About Minapharm:Minapharm Pharmaceuticals is a leading pharmaceutical company in Egypt and the Middle East and the largest end-to-end manufacturer of biological therapies in MEA with over 20 years of experience in cellular and bioprocess engineering.Headquartered in Cairo, Minapharm commercializes over 100 life-saving and life-enhancing products ranging from small molecules to complex bioengineered proteins and viral vectors, with an impressive immunotherapy pipeline.Together with its wholly-owned Berlin-based subsidiary, ProBioGen AG - a world-leading CDMO, Minapharm has established an integrated business model making it the only gene-to-market company in the region.Consolidating its international platform of intelligent biopharmaceutical technologies with the longstanding process development and manufacturing expertise in the MEA, Minapharm, together with ProBioGen, have incorporated MiGenTra GmbH headquartered in Berlin and manufacturing in Cairo, to enhance the accessibility to critical healthcare transforming medicines through product development and commercialization of Biosimilar mABs, Cell, and Gene Therapies and vaccines, at affordable prices in Egypt, and MEA.Minapharm Group of Pharmaceuticals Companies employs a collective workforce of more than 1400 Individuals & continues to expand their workforce with Talented Human Capital.Our Core Values:· Diversity & Respect· Integrity & Accountability· Collaboration· Leadership & Empowerment· Innovation & Continuous LearningJob Summary:The role is responsible for overseeing product registrations, re-registrations, renewals, variations, pricing submissions, and regulatory compliance activities while maintaining strong relationships with the Egyptian Drug Authority (EDA), CADC, NFSA, BIO-INN, and other relevant authorities.Duties & ResponsibilitiesLead the registration, re-registration, and variation activities for pharmaceutical and biological products in compliance with EDA regulations.Prepare and submit applications for new product registrations in accordance with applicable regulatory requirements and decrees.Manage submissions through regulatory electronic platforms and ensure timely follow-up until approval.Prepare and submit stability, quality, and scientific dossiers for human and biological products.Coordinate with Medical Affairs to develop and submit package inserts and supporting documents to regulatory committees.Monitor regulatory updates, decrees, and guidelines issued by the EDA, ensuring compliance and business readiness.Prepare and submit variation requests, including changes related to composition, manufacturers, suppliers, license holders, packaging configurations, and product specifications.Manage pricing and repricing submissions, ensuring successful approval and implementation.Liaise with EDA pricing authorities regarding new product pricing and repricing activities.Prepare and submit renewal and renewal-pricing files through the relevant regulatory systems.Coordinate with inspection authorities, ensuring timely submission of required documentation and closure of regulatory requirements.Prepare dossiers and electronic submissions for CADC and follow up through final approval and product release stages.Coordinate the release of initial commercial batches and bulk products through CADC.Submit and follow up on various regulatory requests, including approved composition copies and release certificates.Initiate and manage Change Control processes related to variations, re-registrations, and pricing updates.Prepare and submit CTD dossiers (Quality and Summary sections) and follow up until final approval.Manage NFSA registration submissions and follow up until license issuance.Act as the primary liaison with BIO-INN for biological products, including new registrations, variations, stability studies, and quality-related submissions.Lead, coach, and develop the registration team to ensure high performance and regulatory excellence.QualificationsEducation: Bachelor’s degree in Pharmaceutical sciences or related field.Experience: 6-9 years in relevant experience.In-depth knowledge of EDA regulations, registration requirements, CTD submissions, variations, renewals, and pricing processes.Experience dealing with CADC, NFSA, BIO-INN, and relevant regulatory authorities.