What You'll Do
The Integral 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.
Global and Regional Regulatory Strategy
Define 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 Oversight




Oversee 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 Control
Coordinate 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 compl

📌 Principal RASSU Specialist (Madrid)
🏢 Cti Clinical Trial And Consulting Services
📍 Madrid