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 Estonia . In this 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. Responsibilities Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees in Estonia; 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 documents required for a clinical study; Identify and assesses legal, financial, and operational risks and escalate to appropriate Contract Lead or Contract Manager; Provide recommendations