Job Description
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 in Kazakhstan, while taking a step further in your professional career.
Office-based in Almaty
You will:
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 teamsAssist with feasibility research and business development requestsQualifications
College/University degree or an equivalent combination of education, training and experienceClinical trial industry experience Prior experience with clinical trial submissions in KazakhstanFull working proficiency in English and Kazakh Proficiency in MS Office applicationsDetail-orientedAbility to learn, plan and work in a dynamic team environmentCommunication, collaboration, and problem-solving skillsAdditional Information