Regulatory Affairs Specialist

Regulatory Compliance & Strategy:

• Act as the primary responsible person for Logistica for logistics services pharmaceutical warehouses to the Egyptian Drug Authority (EDA).
• Formulate and implement updated regulatory affairs policies and procedures to maintain and enhance compliance.
• Develop and implement regulatory strategies and plans for the preparation and submission of new product dossiers.
• Establish regulatory priorities, manage budgets, and allocate resources effectively to meet departmental goals
• Monitor regulatory affairs trends that are related to environmental issues.
• Ensuring that a quality management system is implemented and maintained
• Ensuring that relevant regulatory customer complaints related to are dealt with effectively
• Comply with environmental management’s standards, objectives and trainings.
• Report immediately any environmental incidents.
• Manage the technical aspects of obtaining new pharmaceutical licenses.
• Prepare and submit product variation documents to the EDA.
• Oversee the disposal of expired medicines in strict adherence to EDA regulations.
• Serve as the primary point of contact with regulatory authorities during inspections, audits, and all compliance-related matters.
• Coordinate and attend EDA inspection visits at pharmaceutical warehouses alongside internal teams and clients.
• Build and sustain positive, professional relationships and a strong reputation with EDA personnel.
• Respond promptly and accurately to all letters and inquiries from the EDA.
• Develop, maintain, and update Standard Operating Procedures (SOPs) to ensure full compliance with EDA regulations.
• Ensure strict adherence to EDA Good Storage and Distribution Practices (GSDP) and other relevant quality standards.
• Review and approve critical technical documentation, including Certificates of Analysis (CoA).
• Verify that all product labeling, packaging, and promotional materials are in full alignment with data registered with the EDA.
• Monitor, interpret, and communicate the impact of changes in local and international regulations to the pharmaceutical warehouses.
• Follow up on product analysis with the EDA to secure final Certificates of Conformity.
• Conduct training sessions for various departments on new and updated EDA regulations.
• Ensure timely settlement of all EDA-related fees through consistent reconciliation with the finance team.
• Prepare detailed monthly fee reports for each client in coordination with the finance department.
• Bachelor’s degree in pharmacy or science
• Experience dealing with regulatory authorities and audits.
• Fluent in writing & reading English.
• Attention to detail
• Time Management.
• Analytical skills
• Communication skills

Project management