Regulatory Affairs Manager

📌 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.
• 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 categories
• Advanced project management and risk assessment
• Strong negotiation and authority interaction skills
• High attention to detail and compliance-driven mindset