Rassu Spec Ii (European Lead Role)

Cti Clinical Trial And Consulting Services; Almada; Presencial; EUR 32 000 - 52 000; Tempo integral

Resumo da oferta

CTI Clinical Trial And Consulting Services in Portugal seeks a Regulatory Affairs professional to lead start-up strategies for European trials, coordinate submissions, and ensure country-specific compliance.

You will collaborate with sponsors, sites, and IRBs, adapt ICFs, prepare regulatory dossiers, and maintain TMF quality, with English fluency required. A minimum of 3-5 years of regulatory experience, CTIS familiarity, and cross-country coordination are essential.

Qualificações

• 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

Responsabilidades

• 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/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

Conhecimentos

Regulatory start-up strategy

CTIS familiarity

Documentation quality review

Regulatory submissions coordination

English proficiency

Formação académica

Associate's or Bachelor's degree in allied health

Ferramentas

CTIS

Descrição da oferta de emprego

Descrição do cargo

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 Managersof 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/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