Regulatory Officer

Company DescriptionPSI is a leading Contract Research Organization with almost 30 years on the market, 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 in Munich/PlaneggYour role:Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, including Import and Export license applicationsCommunicate 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 teams Assist with feasibility research and business development requestsQualificationsCollege/University degree or an equivalent combination of education, training and experiencePrior experience with clinical trial submissions in GermanyFull working proficiency in English and GermanProficiency in MS Office applicationsDetail-orientedAbility to learn, plan and work in a dynamic team environmentCommunication, collaboration, and problem-solving skillsAdditional InformationWe offer:Excellent and flexible working conditionsExtensive training and friendly, collegial teamCompetitive salary and benefits packageOpportunities for personal and professional growthIf 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.