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SalaryI am actively seeking a motivated and detail-oriented individual to join my client's team as an EU Clinical Trial Submission Associate. In this crucial role, you will play a key part in ensuring the technical compliance of our Clinical Trial submissions, fostering smooth communication between various functional areas, local offices, external partners, and regulatory authorities.
As a member of the Regulatory Data & Analytics Team (RDA), team, you will work globally to provide strategic support and contribute to the planning, management, and creation of Clinical Trial information within the EMA CTIS system and the Veeva RIM system. This role involves a cross-functional partnership to ensure seamless end-to-end management of European, Middle East, and African Clinical Trial filings in compliance with EU-CTR regulations.
This position is an initial 12-month contract with one of the largest pharmaceutical companies globally. With over 83% of our contractors getting their contracts extended, renewed or being made permanent this is a great opportunity to grow your career by working with some of the best in the industry.
Responsibilities:
* Act as a technical expert in the EMA Clinical Trial Information System (CTIS), ensuring compliance with EU Clinical Trials Regulation for all Clinical Trial submission dossiers.
* Manage and coordinate Clinical Trial Submissions and Notifications in the Regulatory Document Management System, maintaining accurate tracking systems.
* Serve as the technical coordinator for Clinical Trial Submissions and Notifications through the EMA CTIS, ensuring timely and accurate data input for Applications, Modifications, and Notifications.
* Review and triage Requests for Information from Health Authorities through CTIS to relevant cross-functional teams.
* Assist the EU Regulatory Lead in preparing Submission Content Plans and documentation for regulatory deliverables related to Clinical Trials.
* Contribute to the definition, development, and implementation of processes to meet evolving CTIS needs.
* Proactively identify and resolve issues that may impact submission processes or timelines within CTIS.
Qualifications:
* Bachelor's degree in a relevant scientific discipline or equivalent experience.
* Solid understanding of the EMA Clinical Trial Information System (CTIS) and EU Clinical Trials Regulation.
* Previous experience in regulatory affairs, clinical operations, or related fields in the biopharmaceutical industry.
* Strong organizational and project management skills.
* Excellent communication and interpersonal skills.
If you or a friend are looking for a new and refreshing role or have any questions about the position, then give me a call, drop me a message, or apply directly below and get ahead of the crowd! I look forward to hearing from you.
(intern 3117). Please feel free to visit my LinkedIn profile to see my references/recommendations.
NonStop is one of the largest and fastest-growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Luxembourg, Switzerland, Romania, the US and the Czech Republic and we hold labour leasing licences across Europe.
