Regulatory Officer (Clinical Trials Submissions)

PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.We focus on delivering quality and on-time services across a variety of therapeutic indications.Job DescriptionJoin our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.You will:Prepare independently clinical trial submission dossiers for Regulatory and Ethics AuthoritiesCommunicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related mattersReview translations of essential documents subject to clinical trial submissionTrack the regulatory project documentation flowReview documents to greenlight IP release to sitesManage safety reporting to authorities.Deliver regulatory training to project teams.Assist with feasibility research and business development requests.QualificationsCollege/University degreeMinimum 1 year of prior industry experienceFull working proficiency in English and TurkishProficiency in MS Office applicationsAbility to plan, multitask and work in a dynamic team environmentCommunication, collaboration, and problem-solving skills#J-18808-Ljbffr