Regulatory Affairs in Clinical Trials

Company DescriptionPSI is a leading Contract Research Organization with more than 29 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 DescriptionWe are looking for a Regulatory Officer to join our team in regulatory submissions of clinical studies in Mexico (and Latin America). You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.Only CVs in English will be acceptedYour role:Prepare clinical trial submission dossiers for Regulatory AuthoritiesPrepare country level patient facing documentsCommunicate with regulatory authorities, 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 in Pharmacy, Medicine, Life Sciences, or an equivalent combination of education, training and experiencePrior experience with clinical trial submissionsFull working proficiency in EnglishProficiency in MS Office applicationsDetail-orientedAbility to learn, plan and work in a dynamic team environmentCommunication, collaboration, and problem-solving skillsAdditional InformationAdvance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.