Submission Specialist / Regulatory Officer

Company DescriptionPSI 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.Office-based role in Ra'anana , IsraelYou will:Prepare 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 authoritiesDeliver regulatory training to project teamsAssist with feasibility research and business development requestsQualificationsCollege/University degree or an equivalent combination of education, training and experience. Life science degree is a plusPrior experience of at least one year with clinical trial submissions in Israel within the CRO or Pharmaceutical industriesFull working proficiency in English and HebrewProficiency in MS Office applications and `Matarot’ softwareDetail-orientedAbility to learn, plan and work in a dynamic team environmentCommunication, collaboration, and problem-solving skills*Please send your CV in EnglishAdditional InformationIf you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.