EU CTR Submission Lead

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

1. 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 responses.
• Provide subject matter expertise for end-of-study activities, including End-of-Trial (EoT) notifications, Summary of Results, Lay Summary, CSR and CSRr submissions.
• Conduct quality oversight and ensure alignment with EU CTR, EMA guidance, and internal standards operating procedures.

2. Strategic & Cross-Functional Leadership

• Serve as SME for EU CTR and CTIS processes, interpreting regulatory expectations.
• Lead submission readiness activities and coordinate with internal stakeholders (Regulatory Affairs, Clinical Trial Delivery and Clinical Trial Acceleration Units, Country & site Operations and Safety).
• Lead EU CTR Study Submission Team meetings to align submission strategy and timelines.

3. Compliance & Quality Oversight

• Ensure submissions adhere to EU CTR 536/2014, ICH-GCP, EMA guidance, and national requirements.
• Support audits and inspections related to submission activities.
• Contribute to development and maintenance of SOPs, work instructions, and templates.

4. CTIS System Expertise

• Lead complex CTIS activities: dossier creation, document upload, metadata accuracy, lifecycle management, public disclosure settings.
• Troubleshoot system issues and liaise with EMA as needed.
• Train project teams and stakeholders on CTIS functionalities and updates.

Qualifications & Experience

• Bachelor’s or Master’s in Life Sciences or related field.
• 5+ years’ experience with EU CTR submissions and advanced CTIS expertise.
• Strong understanding of EU CTR timelines, dossier content, and results reporting.
• Proven ability to lead complex submission programs.
• Excellent communication, prioritization, and problem-solving skills.
• Experience in pharma, biotech, or CRO.
• Knowledge of regulatory intelligence and EU regulatory strategy. Core Competencies & Skills
• Strategic thinking • Cross-functional leadership
• Problem-solving and analytical skills
• High attention to detail
• Excellent communication