عرفة جروب
Regulatory Officer
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Job Description
Managing product registrationsEnsuring compliance with local regulatory requirementsMaintaining effective communication with the Egyptian Drug AuthoritySupports timely product approvals, lifecycle management, and adherence to applicable laws and guidelines.
Following Regulatory Submissions & Approvals.Documentation & Lifecycle Management.Cross-Functional CoordinationManaging Regulatory file across partners
Experience2–5+ years experience in pharmaceutical regulatory affairs, submissions, product registration, or regulatory lifecycle management.Experience with Egyptian regulatory process and working with the Egyptian Drug Authority (EDA) is highly preferred.Exposure to regulatory submissions/approvals end-to-end (preparation, submission, follow-up, amendment) is a plus.Regulatory Knowledge & SkillsStrong knowledge of local regulatory requirements in Egypt for drug/product registration and maintenance.Understanding of product lifecycle management (renewals, variations, updates, CAPA/changes where applicable).Ability to interpret regulatory guidelines and ensure full compliance in submissions.Detail-oriented approach to regulatory documentation and data integrity.Documentation & ProcessExperience managing regulatory files, ensuring completeness, version control, and traceability.Strong ability to prepare and/or review submission documents and supporting evidence.Familiarity with regulatory timelines, follow-ups, and maintaining submission status.Communication & Stakeholder ManagementAbility to maintain effective, professional communication with the Egyptian Drug Authority and internal/external stakeholders.Strong cross-functional coordination skills (e.g., with QA, RA, regulatory partners, medical, supply chain, quality/compliance).Experience managing regulatory files across partners/vendors and ensuring alignment.Technical / ToolsProficiency in Microsoft Office (Word, Excel, PowerPoint) for regulatory document preparation and tracking.Ability to use document management systems or structured filing tools (if available internally).Soft SkillsExcellent organizational and follow-up skills.Ability to work under deadlines and manage multiple products simultaneously.High confidentiality and compliance mindset.
Requirements & Qualifications
Experience2–5+ years experience in pharmaceutical regulatory affairs, submissions, product registration, or regulatory lifecycle management.Experience with Egyptian regulatory process and working with the Egyptian Drug Authority (EDA) is highly preferred.Exposure to regulatory submissions/approvals end-to-end (preparation, submission, follow-up, amendment) is a plus.Regulatory Knowledge & SkillsStrong knowledge of local regulatory requirements in Egypt for drug/product registration and maintenance.Understanding of product lifecycle management (renewals, variations, updates, CAPA/changes where applicable).Ability to interpret regulatory guidelines and ensure full compliance in submissions.Detail-oriented approach to regulatory documentation and data integrity.Documentation & ProcessExperience managing regulatory files, ensuring completeness, version control, and traceability.Strong ability to prepare and/or review submission documents and supporting evidence.Familiarity with regulatory timelines, follow-ups, and maintaining submission status.Communication & Stakeholder ManagementAbility to maintain effective, professional communication with the Egyptian Drug Authority and internal/external stakeholders.Strong cross-functional coordination skills (e.g., with QA, RA, regulatory partners, medical, supply chain, quality/compliance).Experience managing regulatory files across partners/vendors and ensuring alignment.Technical / ToolsProficiency in Microsoft Office (Word, Excel, PowerPoint) for regulatory document preparation and tracking.Ability to use document management systems or structured filing tools (if available internally).Soft SkillsExcellent organizational and follow-up skills.Ability to work under deadlines and manage multiple products simultaneously.High confidentiality and compliance mindset.
EGjobank Analysis
Quick Role Summary
Opportunity as "Regulatory Officer" at ADI Egypt located in adi on a Full-Time basis, suited for Senior Level candidates, within Marketing & Sales. Key details from listing: Managing product registrationsEnsuring compliance with local regulatory requirementsMaintaining effective communication with the Egyptian Drug…
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