What You'll Do

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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.

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 general, 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, includ

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