Regulatory Affairs & Compliance Pharmacist - Alliance Global

Key Responsibilities

1. Product Registration & Label Compliance (Factory Portfolio)

Review product labels, artworks, and packaging for compliance with MOHAP and Dubai Municipality regulations.
Prepare and submit product registration files for Avicenna-manufactured products (supplements, cosmetics, and medical devices).
Track registration renewals, variations, and approvals, ensuring documentation accuracy and timely updates.
Verify label claims, ingredients, and dosage information before production and printing.

2. Product Classification & Regulatory Submissions (Distribution Portfolio)

Prepare and submit classification and registration requests, free sale certificates, and clearance documents to MOHAP or EDA or municipality.
Support regulatory clearance for imported and exported AGBL products

3. Logistics & Regulatory Support

Coordinate with logistics and customs teams to ensure all shipments meet import permit and regulatory requirements.
Review and release shipping documents, batch certificates, and permits before customs clearance.
Maintain import permit and registration trackers to ensure validity and traceability.

4. LME Store & Warehouse Compliance

Ensure the LME storage facility complies with MOHAP, GDSP, and internal QMS requirements.
Oversee labeling, segregation, and temperature monitoring for all products under storage.
Conduct internal audits and ensure corrective actions for any warehouse-related nonconformities.

5. Supplier & Authority Communication

Liaise with suppliers and manufacturers to collect technical and regulatory documentation (CFS, GMP, ISO, analysis reports).
Communicate with MOHAP, Dubai Municipality, and other authorities for product approvals, clarifications, and inspections.
Support regulatory responses and documentation readiness for authority queries and inspections.

6. GMP & MOHAP Factory Compliance (Avicenna Manufacturing)

Support the GMP and MOHAP licensing requirements for Avicenna manufacturing activities.
Review production-related documentation to ensure only approved products and formulations are manufactured.
Coordinate with QA during MOHAP inspections and factory audits to ensure documentation readiness and compliance.

7. Documentation, Archiving, & Traceability

Maintain a centralized Regulatory Master File System for all products, submissions, and approvals.
Ensure complete traceability of every registration, permit, and correspondence with authorities.
Implement proper document version control, archiving, and retention procedures in alignment with QMS requirements.

8. Audit Readiness & Continuous Improvement

Participate in internal, external, and MOHAP audits related to regulatory and compliance scope.
Support documentation preparation, evidence gathering, and follow-up of audit findings.
Contribute to continuous improvement initiatives by identifying process gaps and proposing corrective actions.
Participate in Management Review Meetings and provide updates on regulatory compliance KPIs and trends.

Job Details