Senior RASSU Regulatory Start-Up Specialist

CTI Clinical Trial and Consulting Services; Portugal; Híbrido; EUR 60 000 - 90 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work opportunities

Resumo da oferta

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.

Qualificações

• 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

Responsabilidades

• 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

Conhecimentos

English fluency

Formação académica

Healthcare degree (Assoc./BSc)

Descrição da oferta de emprego

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.