EU CTR Submission Specialist

Position Summary
The EU CTR Submission Specialist is responsible for planning, preparing, managing, and maintaining regulatory submissions for clinical trials in compliance with EU Clinical Trial Regulation (EU CTR 536/2014) via the Clinical Trials Information System (CTIS). This role covers the entire lifecycle of a clinical trial, from initial application through substantial modifications to end-of-study reporting and public disclosure deliverables.

Key Responsibilities

• Regulatory Submission Management
• Prepare, compile, and submit Initial Clinical Trial Applications (CTAs) in CTIS in line with EU CTR requirements.
• Coordinate and submit Part I and Part II documentation, ensuring compliance, accuracy, and consistency across EU/EEA Member States.
• Manage Substantial Modifications (SMs), safety notifications, administrative changes, and ongoing trial maintenance activities.
• Prepare, coordinate, and submit Requests for Informatio...