Regulatory Manager

компания "oct, russia" we are looking for regulatory manager to join our team in moscow. this employee will be responsible for regulatory support before, during, and after trials as well as provide support with general regulatory information and consultation for the oct team. the responsibilities include: supporting project teams in preparation of trial documents for regulatory submission; reviewing documents for application package provided by sponsor/clinical team and intended for submission, and advising on any amendments/changes if necessary; preparing the list of documents necessary for submission to local regulatory authorities and providing it to the project team, estimating of the timelines for getting all expert opinions, approvals, permissions and licenses; preparing and performing the final check of submission packages to local regulatory authorities; submitting applications and other required documents to local regulatory authorities; monitoring the status of expert examination and receipt of any relevant correspondence issued by regulatory authorities; communicating with regulatory authorities and if necessary consulting with regulatory and other relevant experts; maintaining regulatory records (trackers) and archive; arranging the notarization of translation and/or copies of all documents (e.g. gmp certificates, power of attorney, clarification letters, statements etc.) needed for regulatory submission to be provided notarized; obtaining local insurance; assisting in power of attorney preparation; monitoring new regulatory requirements and informing oct team regarding regulatory changes; conducting regulatory training; developing and keeping updated company’s quality management documents related to work of regulatory processes. requirements: university degree / incomplete university degree; minimum 5 years of experience in clinical trials; understanding of eurasec regulatory requirements and experience of submissions in these countries will be plus; upper-intermediate english spoken and written; ability to work under demanding time schedules; well-developed interpersonal and communication skills; results oriented. we offer: challenging job in a highly qualified team; employee-friendly work environment; competitive salary; professional growth in clinical research field. if you want a career that makes a difference, then you are the person we’ve been looking for and oct clinical is the place for you! apply today!