Regulatory Affairs Specialist – Alliance Global
The Regulatory Affairs & Compliance Pharmacist is responsible for ensuring the compliance of all manufactured, imported, and distributed products under Avicenna and AGBL with UAE MOHAP, DHA, and relevant GCC regulatory requirements. The role covers product registration, classification, labelling, regulatory documentation, logistics support, and factory compliance ensuring that all operations align with current GMP and quality management system standards.
Key Responsibilities
• Product Registration & Label Compliance (Factory Portfolio)
o Review product labels, artworks, and packaging for compliance with MOHAP and Dubai Municipality regulations.
o Prepare and submit product registration files for Avicenna-manufactured products (supplements, cosmetics, and medical devices).
o Track registration renewals, variations, and approvals, ensuring documentation accuracy and timely updates.
o Verify label claims, ingredients, and dosage information before production and printing.
• Product Classification & Regulatory Submissions (Distribution Portfolio)
o Prepare and submit classification and registration requests, free sale certificates, and clearance documents to MOHAP or EDA or municipality.
o Support regulatory clearance for imported and exported of AGBL products in MENA , Africa and other countries.
• Logistics & Regulatory Support
o Coordinate with logistics and Agents to ensure all shipments meet import permit and regulatory requirements.
o Review and release shipping documents, batch certificates, and permits before customs clearance.
o Maintain import permit and registration trackers to ensure validity and traceability.
• LME Store & Warehouse Compliance
o Ensure the LME storage facility complies with MOHAP, GDSP, internal QMS and ISO requirements.
o Oversee labelling, segregation, and temperature monitoring for all products under storage.
o Conduct internal audits and ensure corrective actions for any warehouse-related nonconformities.
• Supplier & Authority Communication
o Liaise with suppliers and manufacturers to collect technical and regulatory documentation (CFS, GMP, ISO, analysis reports).
o Communicate with MOHAP, Dubai Municipality, and other authorities for product approvals, clarifications, and inspections.
o Support regulatory responses and documentation readiness for authority queries and inspections.
• GMP & MOHAP Factory Compliance (Avicenna Manufacturing)
o Support the GMP and MOHAP licensing requirements for Avicenna manufacturing activities.
o Review production-related documentation to ensure only approved products and formulations are manufactured.
o Coordinate with QA during MOHAP and IDO inspections and factory audits to ensure documentation readiness and compliance.
• Documentation, Archiving, & Traceability
o Maintain a centralized Regulatory and legal Master File System for all products, submissions, and approvals.
o Ensure complete traceability of every registration, permit, and correspondence with authorities.
o Implement proper document version control, archiving, and retention procedures in alignment with QMS requirements.
• Audit Readiness & Continuous Improvement
o Participate in internal, external, and MOHAP audits related to regulatory and compliance scope.
o Support documentation preparation, evidence gathering, and follow-up of audit findings.
o Contribute to continuous improvement initiatives by identifying process gaps and proposing corrective actions.
o Participate in Management Review Meetings and provide updates on regulatory compliance KPIs and trends.
Job Details
| Posted Date: | 2026-11-13 |
| Job Location: | United Arab Emirates – Dubai |
| Job Role: | Finance and Investment |
| Company Industry: | Biotechnology |
| Monthly Salary: | US $3,000 |
Preferred Candidate
| Career Level: | Mid Career |
