Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Clinical Trial Submission Associate. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness.


Responsibilities include:

• You will be assigned to one or more products under development to ensure Clinical Trial Application approvals in the EU. As technical experts in the EMA Clinical Trial Information System (CTIS), ensure compliance with EU Clinical Trials Regulation for every Clinical Trial submission dossier through close internal cross-functional collaboration.
• Coordinate for Clinical Trial Submissions and Notifications in the state-of-the-art Regulatory Document Management System and maintain tracking systems.
• Be the critical technical coordinator for Clinical Trial Submissions and Notifications through the EMA Clinical Trial Information System (CTIS), ensuring accurate and timely input of data into the EMA CTIS system for Clinical Trial Applications, Modifications and Notifications.
• Be responsible for reviewing and triaging of Requests for Information from Health Authorities through CTIS to relevant cross functional teams.
• Support the EU Regulatory Lead to prepare Submission Content Plans and documentation for regulatory deliverables, for the management of Clinical Trials.
• Assist with definition, development, and implementation of processes to meet the evolving CTIS needs.
• Raise, inform, and resolve any issues that may impact submission process or timelines within CTIS.

Requirements

• The role is focused on the submissions for the UCTR, EU region only, and it is done through a system which is called CTIS (Clinical Trails Information System). We must have candidates with experience using this system. Would want to understand how many countries were included in the submissions that you have performed in the past.
• Knowledge of regulation and the system, for example, what kind of activities have you performed so far? Including different kind of submissions such as initial application, additional member states, notifications, not substantial modification, and transitional applications. How many are done monthly and to see how widely you are engaged in these kind of activities.
• You must have experience on systems, essential to have CTIS experience or at least some experience with it, for example, six-months.
• Viva Volt - What is your knowledge on Viva Volt (RIM)?
• EU clinical trial understanding – do you know how CTR works? Content base knowledge of the process is great to have too.
• Previous experience in: Reg team admin / administrative assistant / clinical reg admin