Job Description
Position Summary
The EU CTR Submission Lead is responsible for leading and overseeing the full lifecycle of regulatory submissions for clinical trials conducted under the EU Clinical Trial Regulation (EU CTR 536/2014) via the Clinical Trials Information System (CTIS). This role provides strategic submission planning, cross-functional coordination, and subject matter expertise (SME) while ensuring timely, high-quality control, and compliant submissions across the EU/EEA. The Submission Lead is a senior technical leadership role, who plays a pivotal role in mentoring junior team members without direct line management responsibilities.
Key Responsibilities
- Regulatory Submission Leadership
- Lead planning and execution of Initial CTAs, Part I & II submissions, Substantial Modifications (SMs), and all CTIS lifecycle activities.
- Oversee preparation and submission of Requests for Information (RFIs), ensuring high-quality and timely res...