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

CTI; Covington, Raleigh (KY, NC); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Tuition reimbursement

Hybrid work opportunities

Paid parental leave

Health benefits

Job summary

CTI Clinical Trial and Consulting Services seeks a Regulatory Affairs Study Start-Up Manager to lead Regulatory Specialists across multiple studies and countries, ensuring timely, inspection-ready start-up activities and alignment with sponsor strategies.

The role entails regional oversight, coaching, and ongoing education in ICH/GCP, with collaboration across cross-functional teams to maintain compliance and high-quality submissions.

Qualifications

• Bachelor’s degree in an allied health field or equivalent experience.
• At least 10 years of pharmaceutical or CRO regulatory experience.
• Strong knowledge of EU regulations, GCP, ICH guidelines.
• Experience with US/Canada regulatory submissions; regional oversight across countries.

Responsibilities

• Provide day-to-day line management for Regulatory Specialists and Coordinators.
• Coach and mentor team members for leadership and career progression.
• Oversee regulatory timelines, document processes, and study start-up activities.
• Coordinate regulatory resources and staffing for studies across countries.
• Ensure milestones are achieved and regulatory maintenance is completed.
• Lead internal regulatory team meetings and communicate risks and actions.
• Maintain SSU and eTMF records to be inspection-ready.
• Develop and update SOPs and drive process improvements.

Skills

Line management

Regulatory affairs

GCP/ICH knowledge

Cross-functional collaboration

Project management

Education

Bachelor’s Degree in allied health

Tools

eTMF system

Regulatory document processes

Job description

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

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

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

Why CTI?

• Advance Your Career – We invest in your professional growth. Through a structured mentoring program, leadership development courses, and access to ongoing education and training opportunities, including tuition reimbursement, you’ll have the tools to achieve your goals. Our dedicated training department supports your successful career at CTI.
• Be Part of an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with generous health benefits, vacation packages, hybrid work opportunities, and paid parental leave. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.
• Make a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.

Equal Opportunity Employer/Veterans/Disabled

Equal Opportunity Employer
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