Sr. Director, Regulatory Affairs Study Start Up (level dependent on experience)

CTI; Covington, Raleigh (KY, NC); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Tuition reimbursement

Mentoring program

Leadership courses

Hybrid work from home

Health benefits

Paid parental leave

Job summary

CTI Clinical Trial and Consulting Services seeks a Sr. Director, Regulatory Affairs Study Start Up to lead the global RASSU organization from our Covington, KY or Raleigh, NC offices.

You will own budgeting, forecasting, and performance metrics while building a high-performing, geographically dispersed team; ensure regulatory compliance, inspection readiness, and continuous improvement across the function.

Qualifications

• 15+ years of CRO/pharma/biotech regulatory start-up experience with global leadership
• Masters or Doctoral degree in a health-related discipline or equivalent
• Experience leading a large, geographically dispersed global RASSU organization
• Experience owning departmental budgets, forecasts, and performance metrics
• Experience leading transformation, process harmonization, technology implementation, or automation

Responsibilities

• Leads a large, geographically dispersed global RASSU organization through regional/function leaders.
• Establishes strategy, objectives, and accountability aligned with corporate strategy and sponsor commitments.
• Maintains accountability for delivery, productivity, quality, engagement, retention, and financial targets.
• Oversees workforce planning, succession planning, talent development, and performance management.
• Represents CTI in sponsor engagements, governance forums, and bid proposals.

Skills

Strategic leadership

Global team leadership

Budgeting & forecasting

Regulatory affairs

Process improvement

Stakeholder management

Education

Masters/PhD in health

Job description

Sr. Director, Regulatory Affairs Study Start Up (level dependent on experience)

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

Job Summary:

Provides strategic and operational leadership for the global Regulatory Affairs Study Start-Up (RASSU) function, with accountability for organizational performance, delivery quality, financial management, resource capacity, and achievement of corporate and sponsor objectives. Leads a large, geographically dispersed team through regional and functional leaders and establishes clear expectations for performance, productivity, quality, and professional development. Owns departmental budgeting, forecasting, unit and productivity tracking, resource utilization, and financial performance. Provides governance and subject-matter leadership for applicable policies, Global Standard Operating Procedures (GSOPs), work instructions, and supporting processes, ensuring regulatory compliance, operational consistency, inspection readiness, and continuous improvement across the global organization.

What You'll Do:

• Leads a large, geographically dispersed global RASSU organization through regional and functional leaders, ensuring an effective organizational structure, appropriate spans of control, and consistent execution across regions.
• Establishes departmental strategy, objectives, performance expectations, and accountability measures aligned with corporate strategy, regulatory requirements, and sponsor commitments.
• Maintains overall accountability for team delivery, productivity, quality, engagement, retention, and achievement of operational and financial targets.
• Leads workforce planning, capacity management, organizational design, succession planning, talent development, and performance management across the function.
• Attracts, develops, coaches, and retains high-performing leaders and team members; establishes clear expectations and holds leaders accountable for team performance and development.
• Owns development, management, and ongoing forecasting of the departmental budget, including headcount, operating expenses, and functional investments.
• Establishes and oversees unit tracking, productivity measures, resource utilization, forecasting, and financial reporting to ensure alignment with corporate objectives.
• Monitors financial and operational performance, identifies variances and emerging risks, and implements corrective actions to improve efficiency, predictability, and profitability.
• Partners with Finance, Commercial, and Operational leadership to support pricing assumptions, bid development, scope management, and out-of-scope activities.
• Serves as the functional owner or subject-matter authority for applicable GSOPs, policies, work instructions, templates, and supporting tools.
• Leads the drafting, review, editing, approval, implementation, training, and periodic revision of RASSU-related controlled documents.
• Ensures procedures and activities remain compliant with applicable regulations, ICH-GCP requirements, local requirements, and company quality standards.
• Maintains accountability for timely resolution of audit and inspection findings, corrective and preventive actions, quality events, and identified process gaps.
• Defines and monitors departmental key performance indicators, quality measures, cycle times, productivity indicators, and financial metrics; reviews trends and implements targeted improvement plans when expectations are not met.
• Drives global process harmonization, technology adoption, automation, and continuous improvement to enhance quality, efficiency, scalability, and the sponsor experience.
• Represents CTI in sponsor engagements, governance forums, business-development activities, Clinical Operations presentations, and review of bid proposals.

What You'll Bring:

• At least 15 years of CRO, pharmaceutical, biotechnology, or other relevant clinical-research experience, including progressive leadership responsibility for complex global Regulatory Affairs and study start-up activities.
• Master’s or doctoral degree in a health-related discipline, or an equivalent combination of education and experience as determined by CTI Management and Human Resources.
• Demonstrated experience leading a large, geographically dispersed global organization through regional or functional leaders, with accountability for team performance, capacity, quality, and delivery.
• Demonstrated experience owning departmental budgets, forecasts, unit or productivity tracking, resource utilization, and operational and financial performance metrics.
• Experience leading global organizational transformation, process harmonization, technology implementation, or automation initiatives
• Experience supporting commercial strategy, pricing, bid development, scope management, or sponsor governance within a CRO or related environment.

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

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.