Regulatory Affairs Assistant Farnoush Darou Teb (FDTCO)

  • Full Time

  • Tehran

      -   Tehran

Posted 4 months ago

Job Description

- Preparing the forms and documents to be sent to MOH - Visiting MOH persons regularly for new products registration and the approval of current products extension and having close communication with them - Updating the company with the latest regulations of MOH - 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 - Reviewing the CTD's contents - Coordination with foreign companies to obtain necessary documents - Following and being updated for the local regulations and health authorities requirements - Familiar with contract manufacturing and under license manufacturing process and regulations - Gathering and preparing the documents for Iran's Drug List, Brand Registration, Renewal and Variation

Requirements

- Pharmaceutical doctorate degree - At least 3 years’ experience - Good Command of English, both written and spoken - License must be free (regardless to be used by company or not) - High standard of accuracy and professionalism - Time management skills to be able to meet the deadlines - Strong analytical skills, result oriented, hardworking, team worker, problem solver - Excellent in interpersonal relations, self -motivation, loyalty and well-recognizing - Having Computer literacy, Proficient in word and excel and Outlook