RASSU Spec II; European lead

Puesto: RASSU Spec II (European lead role)
What You'll Do:
Assist/Advise project teams on all regulatory requirements for clinical studies
Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings
Review and adapt study specific documents according each country and site requirements
Perform 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 requirements
Receive and process study documentation from sites, check content and quality as well as completeness
Interact 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 review
Compile 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 requirements
Assist with and adapt Informed Consent Form (ICF) according to IRB/IEC requests on country or site level
Assist in preparation, quality check and filing of site adapted ICF according to local requirements
Prepare and QC Clinical Trial Application forms (e.g. CTA, XML) where applicable
Interact with Sponsors as needed; forward regulatory documentation, including final regulatory submission packages, if requested, to Sponsor in accordance with CTI or Sponsor SOPs
Respond 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 requirements
Compiling 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 needed
Accurately 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 paper
Perform review, reconciliation, close-out, and archiving activities of study or project documentation according to CTI SOPs or sponsor SOPs
Assist with preparation for Sponsor or Agency audits and inspections
Assist with QC and QA of various study related Regulatory documents and reports
Oversee translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scope
Attend internal and external study meetings and regulatory status reports for each site and country during study meetings
Sites budgets and Sites contracts management, depending from Countries/Regions
What You'll Bring:
Associate’s or Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience
A minimum of 3 - 5 years of relevant pharmaceutical, site, or CRO Regulatory experience
Expertise in leading regulatory start-up strategy for European clinical trials applications
Hands on experience in coordinating, preparing and submitting Part I and Part II applications under Regulation 536/2014 and using CTIS
Regulatory experience in European countries outside the EU (e.g., UK, Switzerland) is a plus
Fluent in English
About CTI   Advance 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 global 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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