Ruhsatlandırma Uzman Yardımcısı

Bio-gen İlaç

Junior Regulatory Affairs Specialist

·         University degree in Chemistry, Biology, Molecular Biology, Pharmacy and Genetics or similar departments,

·         At least 1-2 years of experience in a similar position, especially the preparation of CTD dossiers

·         Good command of English,

·         Good knowledge of Microsoft Office

·         Completed military service for male candidates.

Job Descriptions:

·         Carrying out the process of preparing the technical package for the relevant medical pharmaceutical product submitted to the health authorities in order to obtain drug licenses, for this;

·         Preparing license application files,

.         Preparing license of specifically homeopathic products application files,        

·         Follow the licensing processes,

·         Creating answers to questions from the authority,

·         Communication with the relevant departments in order to obtain the necessary information and documents,

·         Making English/Turkish translations of documents,

·         To carry out all the necessary studies within the licensing system of the department and to keep the records.