Regulatory Affairs Study Start Up Specialist II; RASSU

Regulatory Affairs Study Start Up Specialist II (RASSU)

• Prepare, review, and manage regulatory submissions under CTR (Clinical Trials Regulation) using CTIS.
• Handle regulatory submissions for medical devices, GMOs, and local country requirements in countries where CTIS is not mandated, including ethics committee submissions.
• Prepare and QC Clinical Trial Application forms (via CTIS or other national applicable systems), where applicable.
• Perform EC/CA and/or other Regulatory Bodies submissions on behalf of sponsors and/or sites, as agreed with the Sponsor and in accordance with each country’s requirements.
• Respond to Deficiency Letters from EC/CA and/or other Regulatory Bodies in liaison with sponsor and study PM or assist sites in their response according to country and site requirements.
• Compile and assess the accuracy and completeness of the regulatory document approval package for drug release (Regulatory Document Study Start Up Checklist).

• Review and adapt study-specific documents according to EU standards.
• Compile regulatory documentation according to CTI/sponsor SOPs.
• Assist with and adapt Informed Consent Form (ICF) according to EC requests at the EU level and liaise with country teams to ensure alignment with local requirements
• Support and modify the ICF in response to EC feedback at the EU level, coordinating with country teams to ensure alignment with local requirements.
• Assist in preparation, quality check, and filing of site-adapted ICF according to local requirements.
• Oversee regulatory document translation, as agreed in the scope.
• Assist with QC and QA of various study-related regulatory documents and reports.

• 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.
• Assist/advise project teams on all regulatory requirements for clinical studies.
• Provide project teams and sponsors with timely, accurate status reports and attend/present updates during internal and external project meetings, as needed.
• Attend internal and external study meetings and provide detailed regulatory status updates for each site and country.
• Interact with sponsors as needed; forward regulatory documentation, including final regulatory submission packages, if requested, to sponsor in accordance with CTI or sponsor SOPs.

• Receive and process study documentation from sites, checking content, quality, and completeness throughout all trial phases (start-up, maintenance, and close-out).
• Accurately apply naming conventions; upload and process all correct and complete regulatory documentation in the eTMF and/or study start-up module or trackers.
• Perform review, reconciliation, close-out, and archiving activities of regulatory documentation according to CTI SOPs or sponsor SOPs.
• Perform compliance assessments according to country requirements and document any activity discovered; notify PMs of any findings.

• Assist with sponsor audits and Regulatory Agency inspections.

• Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience.
• A minimum of 3 years of relevant Regulatory experience within a clinical research organization CRO, pharmaceutical industry, or site environment.

• 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‑lifestyle 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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