- Support all Regulatory Affairs activities in order to achieve and maintain registrations in compliance with all national and regional Regulatory and legal obligations
- Effectively manages priorities in order to implement corrective and preventive actions
- Appropriately applies principles of continuous improvement.
- Annual product reviews and review of stability reports for compliance with Food and Drug Regulations
- Monitoring QA aspects of warehousing practices for compliance with warehouse procedure manuals
- Timely approval of incoming batches, batch inspection and release according to SOPs
- liaising with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations
- Pharmacist (Pharm D.) with valid Pharma license
- 3 plus years’ relevant experience in the regulated pharmaceutical industry, specifically including Quality Assurance, Quality Control, and/or Drug Regulatory Affairs
- Experience with GMP inspections and third party audits
- Understanding of pharmaceutical policies and rules
- Solid computer skills, using MS Office • Fluency in English language especially in writing
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Nikan Pharmed is a Tehran-based company, engaged in supplying high quality healthcare products and supplements. The company is one of the active segments of a big pharmaceutical group which is representing some of the most famous international pharmaceutical companies. We have a dynamic environment and desirable opportunities for all active & smart talents.
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