Senior Regulatory Officer

Senior Regulatory OfficerFull-timeCompany DescriptionWe are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do.  A dynamic, global company founded in 1995, we bring together more than 3000 driven, dedicated and passionate individuals.  We work on the front line of medical science, changing lives, and bringing new medicines to those who need them.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 developing your professional career.Hybrid working arrangement in Prague, the Czech RepublicYour role:Prepare and oversee the preparation of clinical trial submissionActs as a Regulatory Lead in complex clinical trials and programs of clinical trials: coordination of CTIS submission, shared responsibility for developing global and country-level submission strategyPrimary responsibility for discussing submission strategy with sponsorsIdentifying regulatory risks and working on mitigation plansManaging consistency of approaches and regulatory processes across multiple trials in programs of clinical trialsCommunicate 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 experienceA minimum of 5 year's experience with clinical trial submissions in the Czech Republic (experience in Slovakia is an advantage)Extensive experience with Clinical Trial Information System (CTIS)Full working proficiency in Czech (or Slovak) and EnglishProficiency in MS Office applicationsDetail-orientedAbility to learn, plan and work in a dynamic team environmentCommunication, collaboration, and problem-solving skillsAdditional InformationStart your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.Our extensive onboarding and mentorship program will prepare you to fulfil your tasks with the highest standards, offering you:Excellent and flexible working conditions.A unique combination of team collaboration and independent work.Competitive salary and benefits package.If you'd like to hear more about PSI, our organic growth and company culture, and learn more about the studies that we run and our high repeat and referral business rates, please apply for this vacancy.Please submit your CV in English.By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy applyI'm interestedI'm interestedPrivacy Notice