** Please submit your application in English **What You'll Do:Support of Regulatory Affairs Study Start-Up (RASSU) department: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 sites requirementsPerform / oversee IRB/IEC/ 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 and /or perform a QC review of all documentation before submitting to the sites, IRB/EC/CA and/or other Regulatory Bodies according to the local requirementsAdapt Informed Consent Form (ICF) according to IRB/EC requests on country or site level and / or assessing accuracyPreparation and/or quality check and filing of site adapted ICF according to local requirementsPrepare or/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/or 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 SOPsIndependently prepare for Sponsor or Agency audits and inspectionsQC 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 meetingsIndependently represent the Regulatory Department in capabilities and bid defense presentationsIndependently train and mentor less experienced Regulatory staff and other CTI functional department staff regarding regulatory workDevelop relevant SOPs as needs are identified and monitor for process updates and improvements to current SOPsSites 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 the equivalent relevant experienceA minimum of 8 - 10 years relevant pharmaceutical or CRO Regulatory experienceFluent in spoken and written EnglishAbout CTIAdvance Your Career – We 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 integral 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 Impact – At 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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📌 Principal RASSU Specialist (Madrid)
🏢 Cti Clinical Trial And Consulting Services
📍 Madrid