Manager, Submission Management Clinical Trials
Core
Lead end-to-end regulatory activities for clinical trial submissions, ensuring compliance with global health authorities and managing data for EU CTIS.
Role type
Manager, Regulatory Submission Management
Builds
Global Clinical Trial Application (CTA) dossiers and regulatory submissions for health authorities
Domain
Life Sciences / Clinical Trials / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory practices knowledge, EU CTIS data management, Veeva RIM systems proficiency, Project management, Analytical and critical thinking, English communication
Preferred skills
Science or technology degree background, Experience with IVDR coordination, Knowledge of artificial intelligence and automation tools
Technologies
Veeva RIM, CTIS
Responsibilities
Define clinical trial submission strategies and document requirements, Assess core submission deliverables for compliance, Monitor and influence the regulatory assessment process, Manage and track queries with health authorities, Prepare global Clinical Trial Application dossiers, Drive continuous improvement initiatives for regulatory processes
Seniority
Manager, hands-on IC