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) -Coordination with foreign companies and local manufacturing site to obtain necessary documents -Reviewing the CTDs contents and if it is an under licensed product she/he must be familiar with CTD writing -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
Requirements
-Pharm D -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, Brand Registration, under license and contract manufacturing -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, self -motivation, loyalty and well-recognizing -Strong analytical skills, result oriented, hardworking, team worker -Familiar with importation, contract and under license manufacturing process and regulations -Ideal Age Range: 25 - 40
Employment Type
- Full Time
Job Category
Seniority
Details
Employment type
- Full Time
Job Category
Educations
Seniority
