Regulatory Affairs Specialist (Product Importation) Koushan Pharmed

  • Full Time

  • Tehran

      -   Tehran

Posted 2 months ago

Job Description

-Following and being updated for the local regulations and health authorities’ requirements -Updating the company and related departments with the latest regulations of MOH (Ministry of Health) -Updating regulatory data sheets and report it on regular bases. -Coordination with foreign companies and local manufacturing site to obtain necessary documents -Providing SOPs and implementing pharmacovigilance base on PV guidelines -Reviewing the CTDs contents and preparing it for MOH review -Preparing the forms and documents to be sent to MOH -Product registration, license renewal and variation submission -Visiting MOH persons regularly to follow up pending tasks with them -Following all the companies' activities in MOH properly and regularly -Translating the needed documents to be submitted to MOH -Preparing the bilingual (English-Persian) patient leaflet and packing materials


-Pharmacist (Pharm D) -Preferably 2 years’ experience in the field of regulatory affairs of pharmaceutical products -Good understanding of the relevant Iranian MOH and Quality framework -Familiar with IDL and Brand Registration -Familiar with Dossier and CTD -Familiar with the procedure of TTAC -Familiar with pharmacovigilance guidelines -Having a good knowledge in English, written and spoken -Having Computer literacy, Proficient in word and excel and Outlook -Excellent in interpersonal relations, Flexibility and adaptability, self -motivation, loyalty and well-recognizing -Strong analytical skills, data oriented, hardworking, team worker -Familiar with importation, contract and under license manufacturing process and regulations