** Please submit your application in English **What You'll Do:The Global RASSU Lead will serve as a subject matter expert for clinical trial regulatory requirements, ensuring alignment with country-specific requirements, CTI and sponsor SOPs, ICH/GCP, and applicable regulations.
The role will also support regulatory document oversight, study start-up tracking, eTMF/TMF review, audit readiness, training and mentoring, and communication with sponsors and cross-functional teams.General and Regional Regulatory StrategyDefine and oversee regulatory submission strategy in collaboration with sponsors, Project Management, regional teams, and country teams.
Provide oversight for initial submissions, substantial amendments, non-substantial amendments, and other regulatory submissions, as applicable.
Support alignment across global, regional, and country-specific requirements to ensure timely and compliant submissions.
Provide guidance on responses to deficiency letters, information requests, and regulatory authority or Ethics Committee queries.
Regulatory Submissions and Study Start-Up OversightOversee submission packages to Competent Authorities, Ethics Committees, IRBs/IECs, and other regulatory bodies in accordance with applicable requirements.
Support EU/EEA submissions through CTIS, including oversight of Part I and Part II activities, as required.
Coordinate with regional and country teams to ensure completion of national submissions, regulatory documentation, and related requirements.




Oversee study start-up activities from initial planning through regulatory green light and study closure, as applicable.
Study Documentation and Quality ControlCoordinate with sponsors, Project Management, Site Budgets and Contracts, and other functional teams to prepare and adapt required study documents.
Oversee the preparation, review, and adaptation of study documents, including informed consent forms, clinical trial application forms, and other regulatory documents.
Ensure regulatory documents are complete, accurate, and compliant with SOPs, ICH/GCP, GDPR, and country-specific requirements.
Maintain strong quality control practices across document collection, review, processing, version control, and filing.
Regulatory Green Light, TMF/eTMF, and TrackingOversee Regulatory Green Light Package preparation, review, tracking, and completion across regions.
Ensure applicable tracking systems, study start-up modules, eTMF/TMF systems, and regulatory trackers are updated accurately and on time.
Support TMF/eTMF quality checks, reconciliation, close-out, and archiving in accordance with CTI or sponsor SOPs.
Monitor study start-up progress and provide clear, accurate status updates to sponsors, Project Managers, and study teams.
Cross-Functional Communication and Sponsor SupportAct as a key point of email address to guide you through our interview process.
Please ensure you are applying for jobs directly on our website ( or from our verified LinkedIn page.Please NoteWe will never communicate with you via Microsoft Teams or text message We will never ask for your

📌 Global Rassu Regulatory Lead (Madrid)
🏢 Cti Clinical Trial And Consulting Services
📍 Madrid