Principal RASSU Specialist

CTI Clinical Trial and Consulting Services; Portugal; Hybrid; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Hybrid work opportunities

Job summary

CTI Clinical Trial and Consulting Services is seeking a Regulatory Affairs professional to support the Study Start-Up (RASSU) department in a Regulatory capacity. You will advise on country requirements, oversee submissions, and ensure documentation quality across sites and sponsors.

The role involves collaboration with site personnel, PMs, and CRO teams, with a focus on accuracy, compliance, and timely regulatory packages. Hybrid work options may be available in Portugal.

Qualifications

• Associate’s or bachelor’s degree in allied health field such as nursing, pharmacy, or health science or the equivalent relevant experience
• A minimum of 8 - 10 years relevant pharmaceutical or CRO Regulatory experience
• Fluent in spoken and written English

Responsibilities

• Assist/Advise project teams on 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 sites requirements
• Perform / 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 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 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 requirements
• Adapt Informed Consent Form (ICF) according to IRB/EC requests on country or site level and / or assessing accuracy
• Preparation and/or quality check and filing of site adapted ICF according to local requirements
• Prepare or/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/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 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
• Independently prepare for Sponsor or Agency audits and inspections
• 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
• Independently represent the Regulatory Department in capabilities and bid defense presentations
• Independently train and mentor less experienced Regulatory staff and other CTI functional department staff regarding regulatory work
• Develop relevant SOPs as needs are identified and monitor for process updates and improvements to current SOPs
• Sites budgets and Sites contracts management, depending from Countries/Regions

Skills

English fluency

Education

Healthcare degree (Assoc./BSc)

Job description

** 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 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 sites requirements
• Perform / 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 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 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 requirements
• Adapt Informed Consent Form (ICF) according to IRB/EC requests on country or site level and / or assessing accuracy
• Preparation and/or quality check and filing of site adapted ICF according to local requirements
• Prepare or/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/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 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
• Independently prepare for Sponsor or Agency audits and inspections
• 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
• Independently represent the Regulatory Department in capabilities and bid defense presentations
• Independently train and mentor less experienced Regulatory staff and other CTI functional department staff regarding regulatory work
• Develop relevant SOPs as needs are identified and monitor for process updates and improvements to current SOPs
• 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 the equivalent relevant experience
• A minimum of 8 - 10 years relevant pharmaceutical or CRO Regulatory experience
• Fluent in spoken and written 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.