Regulatory Clinical Trial Submissions Associate

CK Group are recruiting for a Regulatory Clinical Trial Submissions Associate to join a biopharmaceutical company who are based in both Uxbridge and Cambridge on a contract basis until the end of 2024.
Salary:
Hourly £25.11 PAYE / £33.01 Umbrella
Company:
Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Location:
The role is predominately home based, but you will need to be able to get to their offices in Uxbridge and Cambridge for team meetings approximately once a month
Regulatory Clinical Trial Submissions Associate role:

• You will ensure technical compliance of our Clinical Trial submissions via the smooth compliant flow of information between all functional areas, local offices, external partners, and regulatory authorities.
• 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.

Your Background:

• You will have experience of CTIS (Clinical Trails Information System) including different kinds of submissions such as initial application, additional member states, notifications, not substantial modification, and transitional applications.
• You will have previous experience of Veeva Volt RIM or similar database system.
• EU Clinical Trial understanding, including CTR.
• Clinical and regulatory submission experience.

Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 56411 in all correspondence.