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.