Regulatory Submissions (Study Start Up) Coordinator

As a Regulatory Submissions Coordinator you will have the opportunity to work within Regulatory Submissions, supporting our many projects and gaining some vital experience. You will be a productive member of the team home-based in Lithuania, and will be mentored and supported as you develop your skills. Working directly with Regulatory Submissions Coordinators, you will gain valuable hands on experience to enable you to develop a career in clinical research.

• Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees in Germany, Austria and Switzerland;
• 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.

• A minimum of a Bachelor's degree is required (preferably in a Life Sciences field);
• Experiencepreparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries;
• No previous industry experience mandatory for junior position level;
• Relevant working experience at a CRO, Pharmaceutical Company, or an investigative site;
• Knowledge of regulatory guidelines in DACH region;
• Excellent organizational and prioritization skills;
• Use to work independently with a proactive approach;
• Knowledge of Microsoft Office;
• Fluency in German and English, additonally Czech is a plus; and
• Great attention to detail and excellent oral and written communication skills.

We kindly ask to submit applications in English. We would appreciate if you could indicate the status of your work permit.