Please submit your application in English
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 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 Tracking

- Oversee 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 Support

- Act 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 Note

- We 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