Principal Rassu Specialist

Cti; Almada; On-site; EUR 40,000 - 65,000; Full time

Job summary

CTI is seeking an experienced Regulatory Affairs professional to support Study Start-Up activities in our European operations. You will advise project teams on regulatory requirements for clinical studies and oversee submissions to IRB/IEC and other authorities.

You will review study documents for country-specific needs, prepare regulatory packages, adapt informed consent forms, and ensure quality and completeness of materials, while collaborating with sites, sponsors, and PMs.

Qualifications

• Associate's or bachelor's degree in allied health field or equivalent experience.
• 8–10 years regulatory experience in pharma/CRO.
• Fluent in English (spoken and written).

Responsibilities

• Assist project teams on regulatory requirements for clinical studies.
• Perform compliance assessments per country requirements.
• Notify PMs of regulatory findings.
• Review study documents for country and site requirements.
• Oversee IRB/IEC submissions on behalf of sponsors/sites.
• Process study documentation quality and completeness.
• QC/QA of regulatory documents and reports.
• Prepare regulatory submissions and adapt ICFs as needed.
• Interact with sponsors, sites, CPCs, CRAs, and PMs.
• Train and mentor junior regulatory staff.

Skills

Regulatory knowledge

Documentation review

Quality control

Project coordination

Fluent English

Education

Bachelor's degree in health field

Job description

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 Managersof 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