Job Description

• 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.