Pharmacist and Regulatory affairs Incharge

Key Responsibilities

• **Import Permits & Shipments:**
• Clear all import permits and shipments requiring MOH (Ministry of Health) approval.
• Ensure that import permits are processed on time, avoiding delays in shipment clearance.
• **Product Classification & Registration:**
• Identify products requiring classification and registration with the MOH, ensuring timely completion of these processes.
• Ensure all products are classified and registered within the required timelines to avoid operational delays.
• **Documentation & Record Keeping:**
• Maintain organized documentation for regulatory and import activities in both hard and soft copy formats.
• Regularly update and review records for accuracy and compliance.
• **Issue Resolution:**
• Address and resolve all regulatory issues promptly, ensuring no delays in the importation process.
• **Weekly Reporting:**
• Prepare and submit weekly reports every Thursday, updating the status of:
• Import permits
• Product classification
• Registration
• MOH fees for reimbursement
• Other related reports
• **Inspection Process Management:**
• Oversee inspection processes and ensure successful clearance, with a presence at the logistics center during inspections.
• **Compliance & Regulation:**
• Stay updated with new MOH regulations and ensure full compliance with them.
• Implement and abide by regulatory requirements in the import and classification process.
• · **Quality Management of Warehouse Operations:**
• Implement and maintain quality management systems in the warehouse.
• Conduct regular audits of warehouse operations to ensure compliance with quality and safety standards.
• Monitor storage conditions to maintain product integrity and prevent damage or contamination.
• Ensure warehouse staff adhere to proper handling, storage, and documentation protocols.
• Address quality-related issues in the warehouse promptly to prevent disruptions to operations.
• **Coordination with Internal Teams:**
• Collaborate with procurement, logistics, and finance teams to ensure timely payment and reimbursement of MOH fees.
• Provide guidance on compliance with MOH regulations throughout the import process.
• **Expiration & Renewal Management:**
• Monitor expiration dates of product registrations and permits, ensuring timely renewals to avoid disruptions.
• **Regulatory Calendar:**
• Create and maintain a regulatory calendar to track important deadlines for permits, registrations, inspections, and fees.
• **ISO 13485 Implementation:**
• Lead the implementation of **ISO 13485** standards for quality management systems in the office.
• Ensure that all processes, documentation, and activities are compliant with ISO 13485 standards for medical device manufacturing.
• Develop and maintain standard operating procedures (SOPs) to ensure ISO 13485 compliance.
• Conduct regular internal audits to monitor compliance with ISO 13485 and recommend improvements as needed.
• **Stock Movement Report Verification:**
• Regularly verify stock movement reports to ensure inventory accuracy and regulatory compliance.
• Identify discrepancies in stock movement and take corrective actions.
• Responsible for Shipment clearance
• **Need Male Candidate**
• **Candidates with MOH license and currently in UAE only need to apply for the post.**
• Pay: AED4,000.00 - AED5,000.00 per month