📌 Key Responsibilities:Develop and execute regulatory strategies aligned with Egyptian regulations for human and veterinary products.Lead preparation, review, and submission of CTD dossiers to the Egyptian Drug Authority.Manage full lifecycle activities including new registrations, variations, renewals, and re-registration for both sectors.Act as the primary contact with EDA departments handling human and veterinary dossiers.Ensure compliance with all local laws, decrees, and veterinary-specific regulatory requirements.Oversee pilot batch production, stability studies, and bio/clinical or veterinary-specific data requirements.Coordinate with internal teams (R&D, Quality, Production, Supply Chain) to ensure regulatory alignment.Monitor regulatory updates in Egypt and assess impact on both human and veterinary portfolios.Manage timelines, regulatory risks, and mitigation strategies to ensure timely approvals.Support regulatory inspections and ensure audit readiness.Lead, mentor, and develop regulatory team members.📌 Qualifications:Bachelor’s degree in Pharmacy or Veterinary Medicine (Pharmacy preferred).13+ years of experience in Regulatory Affairs within Egypt, covering both human and veterinary products.Strong hands-on experience with EDA systems, submissions, and regulatory pathways.In-depth knowledge of CTD structure, lifecycle management, and veterinary regulatory requirements in Egypt.Proven success in obtaining approvals for both pharmaceutical and veterinary products.Excellent leadership, communication, and stakeholder management skills.📌 Preferred Skills:Strong understanding of EDA platforms Strategic regulatory planning across multiple product categoriesAdvanced project management and risk assessmentStrong negotiation and authority interaction skillsHigh attention to detail and compliance-driven mindset