About this role

The job holder will manage and execute regulatory compliance activities for raw materials and finished products, including data preparation, documentation, submissions, and follow-up with regulatory authorities (EDA, NFSA, CADC, NORCB). Acts as primary owner for Raw Materials, COAs, and CRM activities while supporting finished product operations based on workload distribution. Position will be based in our site in Al Obour City and will report to Site Quality Assurance Manager.Your Responsibilities: Full ownership of EDA release, sampling, NFSA (imported & local) for raw material tasks including data preparation, document verification, submission, and SAP release.Raw Materials CADC Management: Prepare and upload CADC files, follow up on analysis results, and manage retained and expired samples.COAs Creation: Create Certificates of Analysis for raw materials and finished productsincluding first batches, random samples, new suppliers, biological and stability products.CRM Management: Handle all CRM activities including accreditation, extensions, whitelist,and coordination with QCand CADCFinished Products Support: Support sampling, CADC submissions, and regulatorydocumentation for finished productsArchiving: Maintain proper archiving of all reports and compliance documents.Financial Tracking: Monitor EDA & NFSA & NRC & EDA Ref Lab fees and support budget calculations Bachelor’s degree in pharmacy, Science, or a related field1–3 years of relevant experience in regulatory affairs, quality, or pharmaceutical operationsStrong knowledge of regulatory requirements (EDA, NFSA, NRC)Attention to detail and documentation accuracyCross-functional coordination (QC, regulatory, finance)SAP and data management proficiencyAnalytical and organizational skillsEnglish language fluency is a must

Requirements

Bachelor’s degree in pharmacy, Science, or a related field1–3 years of relevant experience in regulatory affairs, quality, or pharmaceutical operationsStrong knowledge of regulatory requirements (EDA, NFSA, NRC)Attention to detail and documentation accuracyCross-functional coordination (QC, regulatory, finance)SAP and data management proficiencyAnalytical and organizational skillsEnglish language fluency is a must

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Quality Regulatory Compliance Specialist

About this role

Requirements