- 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 food and drug organization (FDO) 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.