What You'll Do:Assist/Advise project teams on all regulatory requirements for clinical studiesPerform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findingsReview and adapt study specific documents according each country and site requirementsPerform IRB/EC (CA) and/ or other Regulatory Bodies submissions on behalf of sponsors and and/or sites as agreed with the Sponsor and in accordance with each country requirementsReceive and process study documentation from sites, check content and quality as well as completenessInteract with site personnel, CPCs, CRAs and PMs, for document corrections, clarification or resolution of any incomplete and/or incorrect documentation found during document content quality reviewCompile Regulatory documentation according to CTI SOPs, sponsor SOPs and applicable country requirements, perform a QC review of all documentation before submitting to the sites, IRB/EC/CA and/or other Regulatory Bodies according to the local requirementsAssist with and adapt Informed Consent Form (ICF) according to IRB/IEC requests on country or site levelAssist in preparation, quality check and filing of site adapted ICF according to local requirementsPrepare and QC Clinical Trial Application forms (e.g. CTA, XML)where applicableInteract with Sponsors as needed; forward regulatory documentation, including final regulatory submission packages, if requested, to Sponsor in accordance with CTI or Sponsor SOPsRespond to Deficiency Letters from IRB/IEC/CA and/ or other Regulatory Bodies in liaison with sponsor and study PM or assist sites in their response to IRB according to country and site requirementsCompiling and assessing completeness of the Regulatory-Package for drug release (Regulatory Document Study Start Up Checklist)Provide Project teams with accurate periodic status reports in accordance with CTI SOPs and attend internal and external project meetings as neededAccurately apply naming conventions,



upload and process all correct and complete study documentation in the study start-up module or trackers and study specific TMF system whether electronic or paperPerform review, reconciliation, close-out, and archiving activities of study or project documentation according to CTI SOPs or sponsor SOPsAssist with preparation for Sponsor or Agency audits and inspectionsAssist with QC and QA of various study related Regulatory documents and reportsOversee translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scopeAttend internal and external study meetings and regulatory status reports for each site and country during study meetingsSites budgets and Sites contracts management, depending from Countries/RegionsWhat You'll Bring:Associate’s or Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experienceA minimum of 3 - 5 years of relevant pharmaceutical, site, or CRO Regulatory experienceExpertise in leading regulatory start-up strategy for European clinical trials applicationsHands on experience in coordinating, preparing and submitting Part I and Part II applications under Regulation 536/2014 and using CTISRegulatory experience in European countries outside the EU (e.g., UK, Switzerland) is a plusFluent in EnglishAbout CTIAdvance Your CareerWe invest in your professional growth. Our structured mentoring program, leadership development courses, and dedicated training department provide the support you need to excel. We also encourage ongoing education to help you achieve your professional goals.Join an Award-Winning Team – Join a general team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with hybrid work opportunities. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.Make a Lasting ImpactAt CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.
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📌 RASSU Spec II (European lead role) (España)
🏢 Cti Clinical Trial And Consulting Services
📍 España