Regulatory Submissions-Start Up & Contract Specialist (dual role)

Our European activities are growing rapidly, and we are currently seeking a full-time, home-based Regulatory Submissions Coordinator & Contract Specialist (Dual role) to join our Clinical Operations team, in the country of Georgia. As a Regulatory Submissions Coordinator & Contract Specialist (Dual role) you will have the opportunity to work within Regulatory Submissions and contract negotiations, supporting our many projects. You will be a productive member of the team and will be mentored and supported as you develop your skills. Working directly with Regulatory Submissions Coordinators and Contract Specialists, you will gain valuable hands-on experience to enable you to develop a career in clinical research. Please note that this role is not US based and you must be located in the country of Georgia to be considered. Responsibilities Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees in Georgia; Prepare and submit responses to queries and amendments to clinical trial applications; Ensure submissions comply with applicable regulations and guidance documents; Advise team members on changing regulations and compliance requirements; Maintain the Clinical Trial Management System and ensure timely filing of documents; Collection of essential documents and preparation essential documents packages for drug release; Drafting, reviewing, negotiating, and finalizing agreements, termination letters or other legal docum