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.
Global 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 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 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 contact for regulatory study start-up matters, ensuring effective communication with sponsors, Project Management, regional teams, country teams, and other stakeholders.
Support sponsor-facing communication related to submission strategy, timelines, document status, regulatory requirements, and issue resolution.
Collaborate with internal and external teams to identify risks, resolve barriers, and support timely delivery of regulatory milestones.




Lead or participate in study meetings and regulatory discussions, as assigned.
Regulatory Support, Compliance, and Audit ReadinessProvide regulatory guidance to project teams regarding clinical trial submission requirements and country-specific expectations.
Support compliance assessments and escalate notable findings, risks, or delays to Project Managers and RASSU leadership.
Contribute to preparation for sponsor audits, agency inspections, and regulatory quality reviews.
Ensure study documentation is audit-ready, properly archived, and aligned with regulatory and sponsor expectations.
Operational Excellence and Process OrientationDemonstrate urgency and accountability by prioritizing critical tasks and supporting timely delivery without compromising quality.
Support Unit Tracking completion and identify potential out-of-scope RASSU study-related activities, as applicable.
Participate in department and company initiatives to support process improvement, harmonization, and operational excellence.
Maintain a strong focus on accuracy, consistency, confidentiality, and continuous improvement.
What You'll Bring:Bachelor’s degree in an allied health field such as nursing, pharmacy, health science, natural science, or equivalent relevant experience.
Minimum of 8 years of relevant research, regulatory, pharmaceutical, site, or CRO experience.
Strong knowledge of clinical trial regulatory requirements and submission processes, Globally and in EU including EU CTR, CTIS, MHRA, Ethics Committee/IRB/IEC processes, Competent Authority requirements, and applicable national regulations.
Excellent understanding of ICH/GCP, medical and pharmaceutical terminology, SOPs, GDPR, and clinical trial documentation standards.
Experience with regulatory st

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