Job Description

- Supervision of all activities related to the quality of products according to the national and international standards including GMP, GLP, GSP, GDP and etc. - Managing for preparation of all required documents such as guidelines, SOPs, specifications, certificates and reports for different departments. - Managing the process of registration of products and preparing CTDs and other requirements. - Batch Control and release, to check and monitor all aspects of GMP and related issues, to communicate with IRFDA and other foreign authorities as required, to accompany the auditors during GMP inspections - supervise production and studying related documents - Gathering and preparing the documents for Iran Drug List, Brand Registration, Renewal and Variation - Submitting the required documents for registration to Iran MOH - Monitoring and following the registration process both with Iran MOH and related Foreign Companies - Maintaining familiarity with imported and to be imported foreign company products - Keeping up-to-date with changes in regulatory legislation and guidelines - Obtaining marketing permission from Iran MOH according to the regulation - Acting as a link between companies and Iran MOH, ensuring that products are manufactured and distributed in compliance with appropriate legislation - Writing comprehensible, user-friendly, clear Persian product information leaflets and labels - Ensuring that quality standards are met and submissions meet strict deadlines