Manager, Regulatory Affairs Study Start Up (level dependent on experience)

CTI Clinical Trial and Consulting Services; Covington (KY); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Hybrid work

Tuition reimbursement

Leadership courses

Mentoring program

Job summary

CTI Clinical Trial and Consulting Services seeks a Regulatory Affairs Study Start-Up Manager to lead Regulatory Specialists and Coordinators across multiple studies. You will oversee regulatory timelines, ensure compliant, inspection-ready study execution, and provide coaching and development.

This role is office-based at our Covington, KY headquarters or our Raleigh, NC office, with regional oversight and collaboration with sponsors and cross-functional teams to drive timely submissions and

Qualifications

• Bachelor’s Degree in allied health field or equivalent experience.
• At least 10 years pharmaceutical or CRO Clinical Regulatory experience.
• Strong knowledge of EU regulations, GCP, ICH guidelines.
• Experience with central and local regulatory submissions US/Canada; LATAM preferred.

Responsibilities

• Provide day-to-day line management for Regulatory Specialists and Regulatory Coordinators.
• Coach and mentor team members to strengthen technical and leadership capabilities and professional development.
• Oversee regulatory document processes and study-specific regulatory timelines; monitor progress and compliance.
• Assess study-specific regulatory resource needs and establish appropriate teams.
• Ensure regulatory milestones are achieved and study maintenance activities are completed.
• Coordinate support for studies with critical timelines and ensure coverage during absences.
• Contribute regulatory expertise to new business proposals and bid defenses.
• Provide education on ICH guidelines, GCP, and regulatory requirements.
• Maintain knowledge of national/international regulatory requirements and their impact on study start-up.
• Represent Regulatory Affairs in meetings and communicate status updates and risks.
• Lead internal regulatory team meetings to align priorities and drive decisions.
• Monitor SSU and eTMF status and ensure records are inspection-ready.
• Oversee QA/QC reviews of regulatory documents and reports.
• Develop and update SOPs and lead continuous improvement of regulatory processes.
• Provide hands-on Regulatory Specialist support when required.

Skills

Regulatory leadership

Cross-country coordination

Regulatory strategy

GCP/ICH knowledge

Project management

Education

Bachelor’s Degree in allied health

Job description

Job Summary:

The Regulatory Affairs Study Start-Up Manager provides line management, coaching, and professional development for Regulatory Specialists and Regulatory Coordinators while overseeing the delivery and quality of regulatory and study start-up activities across multiple studies and countries. This role provides regional oversight, supports central and local submission strategies, manages regulatory timelines and risks, and partners with sponsors and cross-functional teams to ensure compliant, timely, and inspection-ready study execution.

This position will be office based at either our headquarters located in Covington, KY or our office in Raleigh, NC.

What You'll Do:

• Provide day-to-day line management for assigned direct reports, including objective setting, workload oversight, regular one-to-one meetings, performance reviews, and timely performance feedback
• Coach and mentor team members to strengthen technical and leadership capabilities, support professional development and career progression, and promote engagement, accountability, and succession readiness
• Oversee regulatory document processes and study-specific regulatory timelines; monitor progress and compliance with applicable procedures, identify emerging issues, and implement corrective or alternative solutions as needed
• Assess study-specific regulatory resource needs, establish appropriate teams aligned with study goals, and monitor staffing requirements and performance throughout study delivery
• Ensure regulatory milestones are achieved and study maintenance activities are completed appropriately throughout all stages of study conduct
• Coordinate additional support for studies with critical timelines and ensure appropriate coverage during planned or unexpected staff absences
• Contribute regulatory expertise to new business development proposals and participate in bid defenses and capability meetings
• Provide education and training to support current understanding of International Council for Harmonisation (ICH) guidelines, Good Clinical Practice (GCP), and other applicable regulatory requirements
• Maintain current knowledge of national and international regulatory requirements, guidance, and industry practices, and assess their impact on study-start-up activities
• Represent Regulatory Affairs in internal and external study meetings and communicate clear, timely status updates, risks, and recommended actions
• Plan and lead internal regulatory team meetings to align priorities, address risks, and drive timely decision-making
• Monitor study start-up (SSU) and electronic trial master file (eTMF) status across active studies and ensure records remain current, complete, and inspection-ready
• Oversee quality reviews of SSU and eTMF content to confirm accurate naming, filing, and completeness of regulatory documentation
• Perform or oversee quality control (QC) and quality assurance (QA) reviews of study-related regulatory documents and reports
• Develop and update standard operating procedures (SOPs) as needs are identified, and lead continuous improvement of regulatory processes and supporting procedures
• Provide hands-on Regulatory Specialist support when required by business priorities and available resources

What You'll Bring:

• Bachelor’s Degree in allied health field such as nursing, pharmacy or health science or the equivalent relevant experience
• At least 10 years pharmaceutical or CRO Clinical Regulatory experience
• Strong working knowledge and understanding EU regulations, Good Clinical Practice (GCP) International Council for Harmonization (ICH) regulation and guidelines
• Demonstrated knowledge of and experience with central and local regulatory and ethics submission processes in the United States and Canada; experience across Latin America is also preferred
• Experience providing regional oversight of regulatory and study start-up activities, including coordination across countries, management of submission strategies and timelines, identification and escalation of risks, and alignment with sponsors and cross-functional stakeholders

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 www.ctifacts.com

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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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