• Direct report to CEO
• Follow up with MOH and IFDA for files review and timely checking of submission for new and additional necessary documents.
• Communicate quality control information to all relevant organizational departments.
• Ensuring compliance with regulations set by the Iran FDO.
• Registration of pharmaceutical products and raw materials to obtain a new license and timely action to extend current licenses.
• Review documents as CTD, PMFs, to fulfill MOH requirement for registration.
• Develop professional relationship with MOH staff and monitor relevant changes, Keeping up to date with changes in regulatory legislation and guidelines.
• Liaising and negotiating with regulatory authorities.
• Prepare and reviews technical documents and ensure that high standards of safety and regulatory are executed.
• Ensuring that quality standards are met.
• Follow-ups with the Iranian Ministry of Health on files review and ensures timely submission of additional documentation requested.
• Gathering Pharmacovigilance and ADR reports.
• Planning and implementation of the periodicity of production processes and providing appropriate solutions for production to reduce or eliminate deflections in the processes.
• Undertaking and monitoring good performance, monitoring and product measurements according to control plans.
• Identify critical points in the manufacturing process and specify sampling procedures to be used at these points
• Relevant to method of analysis.
Requirements
• Education: PharmD. Pharmacists
• Good experience in importing and manufacturing ( CMO or direct)of pharmaceutical products and supplements.
• Good history and knowledge on working with MOH and IFDA.
• Having technical license from MOH with at least 5 years’ experience relevant.
• Ability to communicate with foreign partners
• Familiar and provision of SOPs.
• Familiar with TTAC portal of MOH and material registration.
• Fluency in writing, reading and speaking of English language
• Good Communications skills
• Regulatory requirements of organizations (ISO)
• High team work value
• Mastering documenting and documenting
• Experienced in Regulatory affairs
• Ability for working travel (national/international)
• Location: Tehran