Senior Regulatory Affairs study Start Up Specialist

CTI; Covington (KY); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Specialist to manage essential regulatory documentation for clinical studies. This role involves interacting with study teams and regulatory bodies to ensure compliance and timely submissions. You will oversee the quality control of documents, adapt Informed Consent Forms, and prepare Clinical Trial Applications. Join a supportive culture that values work-life balance and offers career advancement opportunities. If you are passionate about making an impact in life-changing therapies, this position is perfect for you.

Benefits

Career advancement through mentoring

Supportive culture with work-life balance benefits

Impactful work on life-changing therapies

Qualifications

• 5+ years of regulatory experience in pharmaceutical or CRO settings.
• Strong understanding of compliance and regulatory requirements.

Responsibilities

• Manage regulatory documentation for clinical studies globally.
• Assist project teams with compliance assessments and submissions.
• Provide periodic status reports and attend project meetings.

Skills

Regulatory Documentation Management

Compliance Assessment

Quality Control (QC)

Clinical Trial Applications

Informed Consent Forms (ICF)

Communication with Regulatory Bodies

Education

Associate’s or Bachelor’s degree in Nursing

Relevant experience in Health Science

Tools

TMF System

Job description

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 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 to each country and site requirements
• Perform / oversee 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 content quality review
• Compile regulatory documentation according to CTI SOPs, sponsor SOPs, and applicable country requirements; perform a QC review of all documentation before submission
• Adapt Informed Consent Forms (ICF) according to IRB / EC requests at country or site level and/or assess accuracy
• Prepare and/or quality check and file site-adapted ICF according to local requirements
• Prepare or QC Clinical Trial Application forms (e.g., CTA, XML), where applicable
• Interact with Sponsors; forward regulatory documentation, including final submission packages, if requested, in accordance with 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 responses
• Assess completeness of the Regulatory Package for drug release (Regulatory Document Study Start-Up Checklist)
• Provide project teams with accurate periodic status reports; attend internal and external project meetings as needed
• Apply naming conventions, upload, and process all correct and complete study documentation in the study start-up module or trackers and TMF system
• Perform review, reconciliation, close-out, and archiving activities according to SOPs
• Prepare for audits and inspections from Sponsors or Regulatory Agencies
• QC and QA of various study-related regulatory documents and reports
• Oversee translation of regulatory documents, if needed, on behalf of Sponsor
• Attend study meetings and provide regulatory status reports for each site and country
• Represent the Regulatory Department in capabilities and bid defense presentations
• Train and mentor less experienced regulatory staff and other departments
• Develop and monitor SOPs for process updates and improvements
• Manage site budgets and contracts, depending on countries/regions

What You'll Bring :

• Associate’s or Bachelor’s degree in nursing, pharmacy, health science, or 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 CRO focused on treatments for chronically and critically ill patients. We support the entire development lifecycle from drug concept to commercialization. Headquartered in Cincinnati, OH, with global operations. Visit www.ctifacts.com for more info.

Why CTI?

• Career advancement through mentoring and training
• Recognized, supportive culture with work-life balance benefits
• Impactful work on life-changing therapies

Note on scams: communication will be from @ctifacts.com emails; apply only via official channels.

Please Note

• No communication via Microsoft Teams or text message
• No requests for bank information during recruitment

Equal Opportunity Employer

We comply with federal employment laws. See the Department of Labor's "Know Your Rights" notice for more info.