About this role

Managing and coordinating clinical trial submission activities within the EU
Working on process optimization for CTA submissions within a team
Managing initial clinical trial application submissions in the EU according to the Clinical Trial Regulation
Maintaining documents in the Clinical Trial Information System (CTIS)
Coordinating responses for requests for information from Health Authorities and Ethics Committees
Ensuring timely submissions in CTIS
Collaborating with different IT platforms

A Master’s degree in life sciences or a relevant field
A minimum of 3 years of experience working with clinical trials and submissions
Strong understanding of EU Clinical Trial Regulation 536/2024 (EU CTR)
Experience with Vault RIM and Vault Clinical (Veeva platforms)
Experience working with CTIS, including document uploads and knowledge of Part I and Part II structures
Experience with process improvement and optimization initiatives
Strong organizational skills and attention to detail
Excellent communication skills in English, both written and spoken
Proactive mindset, with the ability to work independently and drive results.

Opportunities to learn and develop
Short-term incentives
Long-term incentives
Employee benefits based on position level, location, functional area and relevant market benchmarks

Regulatory Submission Professional – Clinical Trial Submissions, EU

Key skills