Global Regulatory Start-Up Director — Strategy & Delivery

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

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.