Quality Regulatory Compliance Specialist

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      "addressCountry": "Egypt"
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    "datePosted": "2026-06-02",
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    "description": "<p><span style=\"font-size: 12pt\">Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets.</span></p>\n<p><span style=\"font-size: 12pt\">With a large footprint reaching patients in over 120 markets, and manufacturing and packaging facilities in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide. The companies Acino, Amoun, Birgi Mefar Group, and M8 are all part of Arcera Life Sciences.</span></p>\n<p><br></p>\n<p>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.</p>\n<p><br></p>\n<p><span style=\"font-weight: bold\">Your Responsibilities:</span></p>\n<p><br></p>\n<ul>\n<li>Full ownership of EDA release, sampling, NFSA (imported &amp; local) for raw material tasks including data preparation, document verification, submission, and SAP release.</li>\n<li>Raw Materials CADC Management: Prepare and upload CADC files, follow up on analysis results, and manage retained and expired samples.</li>\n<li>COAs Creation: Create Certificates of Analysis for raw materials and finished products<br>including first batches, random samples, new suppliers, biological and stability products.</li>\n<li>CRM Management: Handle all CRM activities including accreditation, extensions, whitelist,<br>and coordination with QC <br>and CADC</li>\n<li>Finished Products Support: Support sampling, CADC submissions, and regulatory<br>documentation for finished products</li>\n<li>Archiving: Maintain proper archiving of all reports and compliance documents.</li>\n<li>Financial Tracking: Monitor EDA &amp; NFSA &amp; NRC &amp; EDA Ref Lab fees and support budget calculations</li>\n</ul>\n<p><br></p>\n<p><span style=\"font-weight: bold\">Your Qualifications:</span></p>\n<p><br></p>\n<ul>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Bachelor’s degree in pharmacy, Science, or a related field</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">1–3 years of relevant experience in regulatory affairs, quality, or pharmaceutical operations</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Strong knowledge of regulatory requirements (EDA, NFSA, NRC)</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Attention to detail and documentation accuracy</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Cross-functional coordination (QC, regulatory, finance)</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">SAP and data management proficiency</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Analytical and organizational skills</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">English language fluency is a must</span></li>\n</ul>\n<p><br></p>\n<p>This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!</p>",
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