Regulatory Affairs Consultant

Position Overview Responsible for the end-to-end pharmaceutical registration lifecycle in the Egyptian market, serving as the primary liaison with the Egyptian Drug Authority (EDA). The ideal candidate must independently analyze deficiency letters issued by the EDA, collaborate closely with HQ/domestic regulatory teams to prepare technical responses and dossier revisions, actively manage project timelines, and effectively mitigate registration rejection risks. Reporting To: Regional Head Key Responsibilities Full-Lifecycle Regulatory Management：Lead full-lifecycle registration for chemical finished products and biosimilars in Egypt, including dossier compilation, submission, review tracking, response to deficiencies, and dossier updates. Deficiency Analysis & Cross-Functional Alignment：Receive and independently analyze EDA deficiency letters; collaborate with domestic technical teams to formulate technical solutions and prepare responses, acting as an active technical lead rather than a mere message passing intermediary. Regulatory Intelligence & Risk Assessment：Monitor local EDA regulatory updates, evaluate the impact of regulatory changes on the product pipeline, and provide timely risk assessments and strategic recommendations to leadership. Project Oversight & Milestones Tracking：Track key project milestones, generate regular progress reports, and proactively identify bottlenecks or high-risk issues for early escalation. Dossier & Archive Management：Manage and maintain registration dossiers, approvals/certificates, official correspondence, and product samples to ensure complete traceability in compliance with EDA audit and inspection standards. Inspection Support：Coordinate and support EDA local site inspections; prepare required documentation and work alongside HQ teams to resolve inspection queries. Qualifications & Competencies Regulatory Expertise: Over 8 years of experience in pharmaceutical product registration in Egypt. Deep familiarity with Egyptian EDA regulations for small molecules, biologics/biosimilars, and innovative drugs, with the ability to accurately interpret complex regulatory frameworks. Technical Problem-Solving: Proven capability to interpret EDA deficiency letters, deconstruct complex technical issues, and organize cross-functional teams to deliver precise responses. Risk Management: Strong risk foresight to identify registration approval bottlenecks/rejection risks early and proactively escalate them. Communication Skills: Excellent written and spoken English, capable of smooth and authoritative communication with both the EDA and HQ teams in China. Project & Document Management: Solid skill set in technical document archiving, dossier lifecycle management, and project progress tracking. Show more Show less