Senior Regulatory Affairs Specialist

CTI
US - Kentucky - Covington
January 6, 2025

Job Purpose/ Summary:
Independently manage essential regulatory documentation (as applicable) for submission to country/regional/site Institutional Review Boards (IRB), Ethics Committees (EC), Competent Authorities (CA) and/or other Regulatory Bodies for all clinical studies performed globally.
Interact with, assist, and advise study teams, site personnel, sponsors, and CTI management to facilitate timely collection, assessment and processing of essential regulatory documentation and to provide ongoing status reports about the documentation.
Maintain essential regulatory documentation for multiple studies and perform review, reconciliation, close-out and archiving activities of study or project documentation according to CTI or Sponsor SOPs.

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 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

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
At least 5 years of relevant pharmaceutical, site, or CRO Regulatory experience

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations.
We assist clinical research throughout the lifecycle of development, from drug concept to commercialization.
CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms.
For more information, visit ***

Why CTI?

Advance Your Career - We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow.
We also value ongoing education and training through tuition reimbursement and a dedicated training department.
Join an Award-Winning and Valued Team - We have an award-winning unparalleled culture that can be felt by our employees across 60 countries.
We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave.
We also encourage care for the world around us through our unique CTI Cares program.
Make a Lasting Impact - We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

Important NoteIn light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process.
Please ensure you are applying for jobs directly on our website (***) or from our verified LinkedIn page.

Please Note

We will never communicate with you via Microsoft Teams or text message
We will never ask for your bank account information at any point during the recruitment process

Read the full job description and apply online on the recuiter's web-site

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