EU CTR Submission Lead
Core
Leading the full lifecycle of regulatory submissions for clinical trials under EU CTR 536/2014 via the Clinical Trials Information System (CTIS), ensuring strategic planning, cross-functional coordination, and compliance across the EU/EEA.
Role type
Senior technical leadership (IC) Regulatory Submission Lead
Builds
Regulatory dossiers and submissions for clinical trials
Domain
Life Sciences / Clinical Trials / EU Regulatory Affairs
Deliverable
client delivery
Required skills
EU CTR 536/2014 expertise, CTIS system management, submission lifecycle planning, quality oversight, audit support, SOP development, stakeholder coordination
Preferred skills
Regulatory intelligence, EU regulatory strategy, complex program leadership
Technologies
CTIS
Responsibilities
Lead planning and execution of Initial CTAs, Part I & II submissions, Substantial Modifications, and End-of-Trial notifications; Serve as SME for EU CTR and CTIS processes; Conduct quality oversight and ensure alignment with EMA guidance; Lead submission readiness activities and coordinate with internal stakeholders; Troubleshoot CTIS system issues and liaise with EMA; Train project teams on CTIS functionalities.
Seniority
Senior, hands-on IC with mentorship responsibilities
