{"id":1884827,"url":"https://alion.io/job/logistica-regulatory-affairs-specialist","title":"Regulatory Affairs Specialist","company":{"id":3899357,"name":"Logistica","domain":"logistica.com.eg","url":"https://alion.io/company/logistica-3","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":null,"truth_index":null},"role":"Public Policy","role_family":"Public Policy","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["6th of October City, Egypt"],"countries":["EG"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":16000,"max_usd":46000,"period":"year","method":null,"sample_n":964},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-30T11:54:20Z","employer_posted_date":null,"last_verified_at":"2026-09-30T11:54:20Z","board_verified":false,"closed_at":null,"days_open":27,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":27},"description":"Regulatory Compliance & Strategy:\n\n· Act as the primary responsible person for Logistica for logistics services pharmaceutical warehouses to the Egyptian Drug Authority (EDA).\n· Formulate and implement updated regulatory affairs policies and procedures to maintain and enhance compliance.\n· Develop and implement regulatory strategies and plans for the preparation and submission of new product dossiers.\n· Establish regulatory priorities, manage budgets, and allocate resources effectively to meet departmental goals\n· Monitor regulatory affairs trends that are related to environmental issues.\n· Ensuring that a quality management system is implemented and maintained\n· Ensuring that relevant regulatory customer complaints related to are dealt with effectively\n· Comply with environmental management’s standards, objectives and trainings.\n· Report immediately any environmental incidents.\n· Manage the technical aspects of obtaining new pharmaceutical licenses.\n· Prepare and submit product variation documents to the EDA.\n· Oversee the disposal of expired medicines in strict adherence to EDA regulations.\n· Serve as the primary point of contact with regulatory authorities during inspections, audits, and all compliance-related matters.\n· Coordinate and attend EDA inspection visits at pharmaceutical warehouses alongside internal teams and clients.\n· Build and sustain positive, professional relationships and a strong reputation with EDA personnel.\n· Respond promptly and accurately to all letters and inquiries from the EDA.\n· Develop, maintain, and update Standard Operating Procedures (SOPs) to ensure full compliance with EDA regulations.\n· Ensure strict adherence to EDA Good Storage and Distribution Practices (GSDP) and other relevant quality standards.\n· Review and approve critical technical documentation, including Certificates of Analysis (CoA).\n· Verify that all product labeling, packaging, and promotional materials are in full alignment with data registered with the EDA.\n· Monitor, interpret, and communicate the impact of changes in local and international regulations to the pharmaceutical warehouses.\n· Follow up on product analysis with the EDA to secure final Certificates of Conformity.\n· Conduct training sessions for various departments on new and updated EDA regulations.\n· Ensure timely settlement of all EDA-related fees through consistent reconciliation with the finance team.\n· Prepare detailed monthly fee reports for each client in coordination with the finance department.\nRequirements\n· Bachelor’s degree in pharmacy or science\n· Experience dealing with regulatory authorities and audits.\n· Fluent in writing & reading English.\n· Attention to detail\n· Time Management.\n· Analytical skills\n· Communication skills\nProject 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