Overview

Reference Number: JO-2401-527574
EU Clinical Trial Submission Associate
Rate: Negotiable
Job Type: Permanent
Location: Cambridge

Regulatory Affairs – EU Clinical Trial Submission Associate

Uxbridge/ Cambridge, UK – Hybrid/Remote

£25.10 Per Hour via PAYE

An exciting opportunity to join a leading pharmaceutical company and support a leading regulatory operations team with EU CTR Clinical Trials Management. In this vital role, you will ensure technical compliance of Clinical Trial submissions via the smooth compliant flow of information between all functional areas, local offices, external partners, and regulatory authorities.

 

·       Supporting the regulatory operations teams with submissions for clinical trials in Europe through the new EU CTR regulation.

·       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 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 the definition, development, and implementation of processes to meet the evolving CTIS needs.

·       Raise, inform, and resolve any issues that may impact the submission process or timelines within CTIS.

Requirements

·       12 to 18 months of experience working in a similar Regulatory Affairs operations role.

·       Previous experience working with the CTIS (Clinical Trails Information System) is a must.

You would be joining the Regulatory Data & Analytics Team (RDA), part of the Global Regulatory Operations function under R&D. We work as a global team providing strategic support, and where required contribution to planning, management, and creation of clinical trial information within the EMA CTIS system and the Veeva RIM system. The EUMEA RDA work is a cross functional partnership to ensure seamless end-to-end management of European, Middle East and African clinical trial filings to follow EU-CTR regulations.

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