• Implementation & supervision of health authorities and regulations
• Ensures that current registration requirements are available, communicated and implemented
• Compiles and submits registration files for new products
• Follow-ups with the Iranian Ministry of Health on files review and ensure timely submission of additional documentation requested
• Compiles and submits renewal files and updates of approved products
• Proof-reads labeling items
• Responsible for authorization for distribution for imported shipment based on local regulations
• Supervision, approval and attaining authorization (from HAs) for imported shipments
• Report customer complaints in accordance with NNAS and Local requirements
Requirements
• University Qualifications: Pharmacist (Pharm D)
• Experience within Regulatory Affairs and/or Quality Assurance is a requirement while the candidate should be familiar with Product Registration and MOH Regulations.
• You should be able to demonstrate the ability to work on your own initiative and have excellent customer service and good IT skills.
• A good understanding of the relevant Iranian Regulatory and Quality framework is required.
• Good communication skills, time management and high attention to details and accuracy are also very important parts of this role.
• Fluency of Farsi/English is required.
• The position is based in Tehran, Iran.
• Ability to establish a high-quality cross-functional communication is also important, as this unit is naturally involved with all other units.