EU CTR Submission Lead

About the role

The EU CTR Submission Lead leads and oversees the full lifecycle of regulatory submissions for clinical trials under the EU Clinical Trial Regulation (CTR 536/2014) via the Clinical Trials Information System (CTIS). It is a senior technical leadership role providing strategic submission planning, cross-functional coordination and subject matter expertise, ensuring timely, high-quality and compliant submissions across the EU/EEA. The role mentors junior team members without direct line management responsibility.

Key responsibilities

• Lead planning and execution of initial CTAs, Part I and II submissions, substantial modifications and all CTIS lifecycle activities, including RFIs and end-of-study activities such as EoT notifications, summary of results, lay summaries, CSR and CSRr submissions.
• Serve as SME for EU CTR and CTIS, interpret regulatory expectations and coordinate with Regulatory Affairs, Clinical Trial Delivery and Acceleration units, country and site operations and safety.
• Lead EU CTR study submission team meetings to align strategy and timelines.
• Ensure compliance with EU CTR, ICH-GCP, EMA guidance and national requirements, support audits and inspections, and contribute to SOPs, work instructions and templates.
• Lead complex CTIS activities: dossier creation, document upload, metadata accuracy, lifecycle management and public disclosure settings, troubleshoot system issues and liaise with EMA, and train project teams on CTIS.

Required profile

• Bachelor's or Master's degree in Life Sciences or a related field.
• 5+ years of experience with EU CTR submissions and advanced CTIS expertise.
• Proven ability to lead complex submission programs.
• Experience in pharma, biotech or CRO.

Required skills

• Strong understanding of EU CTR timelines, dossier content and results reporting.
• Knowledge of regulatory intelligence and EU regulatory strategy.
• Excellent communication, prioritisation and problem-solving skills.