Regulatory Submissions Manager - EMEA

About the role

We are seeking a Regulatory Submissions Manager for the EMEA region to lead the planning and execution of regulatory authority, IRB/EC and third‑party submissions across multiple clinical sites. The role works within a matrix organisation, collaborating with project teams and clients to ensure timely, compliant delivery of submission packages.

Key responsibilities

• Develop and implement submission strategies, create timelines and track milestones for RA, IRB/EC and third‑party submissions.
• Coordinate responses to queries, manage country‑specific requirements and provide regular status updates to project teams and clients.
• Prepare, review and quality‑check core study documents, compile country packages and oversee their maintenance and close‑out.
• Provide regulatory advice, monitor changes in legislation (e.g., EU CTR) and assess impact on projects.
• Support local teams in liaising with regulatory bodies and manage user access to the Clinical Trials Information System (CTIS).
• Monitor deliverables against Green Light and Site Ready to Enroll milestones, flag risks and ensure budget compliance.
• Participate in quality‑assurance activities, drive process improvements and support audit/inspection readiness.

Required profile

• Bachelor’s degree in Life Sciences or a related field (higher qualification preferred).
• Relevant experience in regulatory submissions for clinical trials within the EMEA region.
• Strong knowledge of regulatory authorities, IRB/EC processes and the EU Clinical Trials Regulation.
• Ability to work in a matrix environment and communicate effectively with cross‑functional teams.

Required skills

• Proficiency with the Clinical Trials Information System (CTIS).