Global Regulatory Start-Up Manager

CTI Clinical Trial and Consulting Services; Raleigh (NC); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Hybrid work from home opportunities

Health benefits

Tuition reimbursement

Job summary

CTI Clinical Trial and Consulting Services is seeking an experienced Regulatory Affairs Study Start-Up Manager to lead a team of Regulatory Specialists and Coordinators, ensuring compliant, timely study startup activities across multiple studies and countries. The role features regional oversight, risk management, and collaboration with sponsors and cross-functional teams.

The position is office-based at our Raleigh, NC or Covington, KY headquarters, with a focus on study start-up, regulatory

Qualifications

• Minimum 10 years pharmaceutical or CRO regulatory experience.
• Strong knowledge of EU/ICH/GCP guidelines and US/Canada submissions.
• Experience coordinating cross-country regulatory activities and timelines.

Responsibilities

• Provide day-to-day line management, objective setting, and performance feedback for Regulatory Specialists and Coordinators.
• Coach and mentor team members to develop regulatory and leadership capabilities.
• Oversee regulatory document processes and study timelines, ensuring compliance and inspection readiness.
• Assess study regulatory resource needs and align teams with study goals and timelines.
• Ensure regulatory milestones are met and study maintenance activities are completed across all stages.

Skills

Leadership

Regulatory expertise

Cross-functional collaboration

Mentoring

Education

Bachelor's degree in allied health or equivalent

Job description

CTI Clinical Trial and Consulting Services is seeking an experienced Regulatory Affairs Study Start-Up Manager to lead a team of Regulatory Specialists and Coordinators, ensuring compliant, timely study startup activities across multiple studies and countries. The role features regional oversight, risk management, and collaboration with sponsors and cross-functional teams.

The position is office-based at our Raleigh, NC or Covington, KY headquarters, with a focus on study start-up, regulatory