CTI Clinical Trial and Consulting Services · 9 hours ago

Senior Regulatory Affairs Specialist

United States

Full-time

Remote

Senior Level

5+ years exp

Maximize your interview chances

BiotechnologyConsulting

Growth Opportunities

Insider Connection @CTI Clinical Trial and Consulting Services

Discover valuable connections within the company who might provide insights and potential referrals.
Get 3x more responses when you reach out via email instead of LinkedIn.

Responsibilities

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 / oversee IRB/EC/CA 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

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

Represent the Regulatory Department in capabilities and bid defense presentations

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

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Regulatory documentation managementClinical trial submissionsCompliance assessmentsQuality control (QC) reviewInformed Consent Form (ICF) adaptationRegulatory submissions packagesRegulatory-Package compilationRegulatory audits preparationSOP developmentPharmaceutical experienceCRO experienceTranslation of regulatory documentsHealth science degreeMentoringProject management