Regulatory Officer

PSI is a leading Contract Research Organization with 30 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.
Join 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.
Hybrid in Kyiv, Ukraine
Your role will include:
Liaising with clinical project teams to procure documents required for regulatory & ethics committee submissionsPreparation of regulatory and ethics committee submission dossiersReview of translations of essential documents subject to clinical trial submissionsTracking regulatory project documentation flow and progress reportingTracking changes/amendments to legislation requirements related to clinical researchMaintaining the database of regulatory requirementsCommunication point for ethics committees and regulatory authoritiesEnsuring accurate and timely reporting to ethics committees and regulatory authoritiesCommunication line for clinical project teams and PSI support services on regulatory mattersDelivering regulatory-related training, as required
College/University degree in Pharmacy, Medicine, Life Sciences, or an equivalent combination of education, training and experiencePrior experience with clinical trial submissions in Ukraine and knowledge of local regulatory environmentFull working proficiency in English and UkrainianProficiency in standard MS Office applicationsExcellent communication, planning and organizational skillsDemonstrated ability to multi-task and work effectively in a fast-paced environmentTeam oriented with excellent customer service and interpersonal skills, including a positive attitude to tasks and projects
We offer:
Flexible working conditionsExtensive training and friendly 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.
Please submit your CV in English.