هماهنگ‌کنندۀ امور رگولاتوری

Job Description

Your responsibilities include, but are not limited to: ● Implementing and follow-up of all technical and scientific affairs in the process of importing raw materials, production, and distribution. ● Obtaining legal permission for importation and clearance of products. ● Implementing all instructions issued by the Iran FDA regarding the production and distribution of medicine, collecting items, and submitting reports to the Iran Food and Drug Administration. ● Control of batch Records of each batch of pharmaceutical products in order to include all product information and quality control results and its compliance with CTD. ● Release of each product batch based on the batch record documentation for delivery to the sub-distributors by signing the relevant form. ● Providing timely reports on destruction, recall, and counterfeit products. ● Required actions to obtain, modify or renew the manufacturing license of products ● Assisting Regulatory Affairs Manager in Recall management. ● Assisting Regulatory Affairs Manager in PMQC management. ● Assisting in the management of ADRs in collaboration with the pharmacovigilance manager. ● Monitoring and following up on complaints, technical and quality defects of medicines (referral and follow-up of complaints from the relevant company, Iran Food and Drug Administration, Pharmacovigilance manager if used, etc.). ● Assisting Regulatory Affairs Manager in Return management. ● Assisting Regulatory Affairs Manager in Destruction management. ● Ensuring compliance with GMP principles in the production process. ● Ensuring compliance with the conditions of storage and transportation of products from the manufacturer to the warehouse of the distributor. ● Monitoring the storage conditions of retained samples and stability study of samples. ● Informing the Iran Food and Drug Administration about any changes made to the CTD (Variation). ● Informing any variation, including packaging, box contents such as dosage form, batch number, expiration date, etc., which is not in accordance with issued license and relevant regulation to the Iran Food and Drug Administration, technology transfer department, supply chain, and sales, marketing, and business development. ● Collaborating in issuing the release form of manufactured products. ● Participation in training courses is held by the Iran Food and Drug Administration. ● Information transfer related to all regulations of the Iran FDA regarding the production and testing of pharmaceutical products to the relevant units in Rougine Darou and monitoring its proper performance. ● Receiving reports and critical deviations in the production process from the technology transfer manager and making a final decision about it (according to the relevant instructions). ● Release of the product after receiving the documents from the technology transfer department and performing a Batch Record review. ● Periodic audit of the manufacturing site. ● Cooperation with the marketing and business development department in order to review and comment on promotional materials (leaflets, pharmaceutical magazines, etc.). ● Cooperation with the marketing and business development department in order to web site information management. ● Providing the necessary training to the customs and clearance expert to supervise customs warehouses, observing the requirements of product shipment transportation, data logger transfer and sampling of the shipments and how to transfer samples, and periodic control of them. ● Management of samples sent to the laboratories of the Iran Food and Drug Administration. ● Technical supervision of the customs, the labeling company, and the warehouses of the distribution company through periodic or extraordinary audits. ● Collaboration with the Market Access department in conducting pharmacoeconomic studies. ● Cooperation with the medical department in preparing required documents for molecule registration in the Iran Drug List. ● Collaboration with Compliance Officer in performing Due Diligence (quality section). ● Implementation of the Quality Agreement process with distribution companies. ● Presenting regular reports about carried-out activities to Regulatory Affairs Manager. ● Performing other given duties by Regulatory Affairs Manager. ● Controlling the method of archiving records (hard copy and electronic) in the department. ● Safekeeping the company properties, protecting the working place.