EU CTR Submission Group Lead

Position Summary

The EU-CTR EU-CTR Submissions Group Lead is a critical leadership role overseeing operational activities related to end-to-end trial submissions and lifecycle management under the EU Clinical Trials Regulation (EU CTR 536/2014). This role ensures the efficient, timely, and compliant execution of submissions via the Clinical Trials Information System (CTIS).

Responsible for managing a team of submission specialists and submission leads, the position provides leadership, compliance oversight, and operational excellence for EU clinical trials. The role is also the primary escalation and decision-making point for EU-CTR operational challenges, ensuring alignment with organizational objectives regulatory requirements, and clinical trial timelines.

Key Responsibilities

1. Regulatory Submission Leadership

• Oversee planning and execution of Initial CTAs, Part I & II submissions, Substantial Modifications (SMs), and lifecycle management in CTIS.

• Ensure timely, high-quality RFI responses.

• Lead end-of-study submissions: EoT notifications, Summary of Results, Lay Summary, CSR/CSRr packages.

• Ensure overall compliance with EU CTR, EMA guidance, and internal SOPs.

2. Strategic & Operational Oversight

• Define submission strategies and oversee implementation across assigned programs.

• Collaborate with internal stakeholders (Regulatory Affairs, Clinical Trial Delivery and Clinical Trial Acceleration Units, Country & site Operations and Safety).

• Identify process gaps and implement operational improvements.

• Represent the submission Study Management Team meetings and leadership discussions.

3. Compliance & Quality Governance

• Ensure adherence to EU CTR 536/2014, ICH-GCP, and evolving EMA guidance.

• Lead inspection and audit readiness for CTIS processes.

• Maintain SOPs and ensure documentation accuracy and consistency.

4. CTIS Expertise & System Ownership

• Act as senior SME for CTIS operations, troubleshooting, training, and system governance.

• Oversee metadata accuracy, dossier alignment, public disclosure settings, and lifecycle completeness.

• Liaise with EMA for complex system issues.

5. People Leadership & Team Management

• Manage a team of EU CTR Submission Specialists and leads, including hiring, performance reviews, development planning, and coaching.

• Distribute workload effectively and ensure adequate resource allocation.

• Lead training, capability building, and continuous improvement initiatives.

• Foster a culture of quality, collaboration, and accountability.

Qualifications & Experience

• Bachelor's or Master's in Life Sciences or related field.

• 5+ years experience with EU clinical trial submissions and CTIS.

• Demonstrated people management experience.

• Strong knowledge of EU CTR results reporting and transparency requirements.

• Excellent leadership, communication, and decision-making skills.

• Experience in pharma, biotech, or CRO.

• Experience leading submission teams globally or regionally.

• Expertise in public disclosure and anonymization

Core Competencies & Skills

• Leadership and team development

• Strategic thinking

• Advanced regulatory expertise

• Operational excellence

• Strong communication skills

• Quality mindset and attention to detail