Bioequivalance Supervisor

Established in 1953 with 100% Turkish capital, Bilim Pharmaceuticals stands as one of the foremost leaders in the Turkish pharmaceutical industry. With state-of-the-art manufacturing facilities in Gebze and Çerkezköy, a dedicated team of over 2,500 professionals, and a portfolio of more than 200 licensed products, we proudly advance human health in Turkey and extend our expertise to over 70 countries worldwide.Ranked among the top three of nearly 500 pharmaceutical companies operating in Turkey, we continue to grow with strength and stability — driven by operational excellence and a steadfast commitment to improving quality of life.We are looking for a “Bioequivalance Supervisor” for CMC Management team at Gebze or Beyoğlu location. A brief job description of the position and preferred qualifications for the suitable candidates are defined below.QUALIFICATIONDegree in preferably Pharmacy or Chemistry or Chemical Engineering or Biology or Molecular Biology and Genetics or Bioengineering or Biomedical Engineering,At least 7 years of experience in Bioequivalance, Bioavailability studies, Biowaiver, Clinical Trials in Pharmaceutical Industry,Knowledge about national and international current regulations and guidelines related to Bioequivalence, Bioavailability studies, Biowaiver, Clinical Trials,Fluent in English (able to communicate effectively in written and spoken English),Analytical thinking and problem solving focused,Effective communication, team worker and coordination skills,Good knowledge of Microsoft Office,No military obligation for male candidates.JOB DESCRIPTIONTo ensure Bioequivalence/Bioavailability studies within the scope of Human Pharmaceuticals, new product studies are carried out in accordance with current national and international regulations,To ensure the research of reference products,To conduct literature research within the scope of the study design of the products to be studied in Bioequivalence/Bioavailability studies,To contact with Contract Research Organisation (CRO) within the scope of the study to be carried out,To prepare the investigational medicinal products to be used in Bioequivalence/Bioavailability studies in accordance with the regulation and to ensure that they are delivered to the CRO,To follow all processes related to the initiation, conduct and reporting of Bioequivalence/Bioavailability studies in CRO,To ensure the preparation of the relevant Modules (Module 5 and other relevant sections) in CTD format within the scope of the Bioequivalence/Bioavailability study,To carry out literature researches on biowaiver writings and to prepare the report,To ensure the preparation of answers to Clinical, Bioequivalence/Bioavailability, Biowaiver questions from the Ministry of Health and Authorities in line with EMA/FDA/ICH/TITCK requirements, to coordinate with other departments to provide the necessary documents,To evaluate change controls within the scope of Bioequivalence/Bioavailability studies and to ensure that necessary actions are taken,To ensure that all relevant correspondence and documents are archived,To plan and follow up the actions according to the decisions taken at the meetings and the targets set,To create and follow the work / time plans of the team reporting to him/her,To follow national and international regulations, legislations and guidelines regarding the Bioequivalence/Bioavailability studies and Biowaiver processes of Medicinal Products for Human Use; to ensure coordination to ensure that the work carried out meets the current requirements.In connection with your job application to Bilim İlaç Tic. A.Ş. (“Bilim Pharmaceuticals”), any personal data you provide will be processed by Bilim Pharmaceuticals, as the data controller, in compliance with the Personal Data Protection Law No. 6698. This processing is done to collect, evaluate, and manage recruitment activities. For more information on how Bilim Pharmaceuticals processes your data, please visit: https://www.bilimilac.com.tr/en/protection-of-personal-data