About the job The Regulatory Affairs Study Start-up (RASSU) Department is seeking a dedicated individual to provide comprehensive administrative and regulatory support on clinical trials study submissions. This role will be instrumental in ensuring the smooth management and execution of regulatory affairs processes related to clinical trial submissions and ongoing compliance. What You'll Do Assist in compilation and revision of Regulatory Affairs (RA) documents required for clinical trials submissions, primarily in the UK, but also in other regions as needed Coordinate with with local study teams for RA documents collection and checks, when applicable, primarily in the UK, but also in other regions as needed Contact research sites to obtain maintenance documents throughout the trial Conduct quality checks of documents in the study start up module and the eTMF Generate and review expiration reports and reconciliation reports to ensure compliance and completeness. Assist in managing the RASSU SharePoint platform for document storage and collaboration.. Assist in preparation of study submission packages (Initial Submissions, Substantial Amendments and Non-substantial Amendments) to Ethics and Regulatory Bodies, according to country-specific requirements, primarily in the UK, but also in other regions as needed Arrange for shipments tracking, and retrieval of regulatory documents and packages as needed. Manage the translation request of documents, liaison with the translation Vendor. Assist in the preparation of Suspected Unexpected Serious Adverse Reactions (SUSARs) submission packages for both Central and Local Ethics Committees, as required in applicable countries. Assist in the preparation and completion of specific trackers to monitor project progress Apply standardized naming conventions, upload study documentation in the study start-up module or trackers and study specific TMF system whether electronic or paper Provide backup support for RA activities, as needed Offer additional administrative administrative support to RASSU team members Participate in relevant training sessions to stay current with industry practices and regulatory updates. Assist in the development of Project specific Work Instructions Update RASSU specialists and Directors on outstanding items, and issues as they arise Attend weekly team meetings, prepare and distribute agendas, prepare and distribute meeting minutes, if requested What You Bring 0 – 1 year of research related experience and or regulatory experience Experience providing sound basic knowledge of medical and pharmaceutical terminology Experience providing good understanding of the drug development and clinical trial process Experience in using Microsoft tools to edit, reformat and finalize legal regulatory documents Bachelor’s Degree in allied health fields such as nursing, pharmacy or health/ natural science Excellent verbal and written communication skills Excellent command of English language (verbal and written) Excellent organizational and record retention skills Excellent interpersonal skills Strong computer skills Ability to work independently Ability to handle multiple tasks and manage time efficiently Important Note In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page. Please Note We will never communicate with you via Microsoft Teams or text message. We will never ask for your bank account information at any point during the recruitment process.