Regulatory Start-Up Manager: Study Delivery

CTI; Covington (NC); On-site; USD 140,000 - 180,000; Full time

Job summary

CTI Clinical Trial and Consulting Services seeks a Regulatory Affairs Study Start-Up Manager to lead regulatory teams and ensure timely, compliant start-up activities across multiple studies and countries. The role emphasizes coaching, process improvements, and collaboration with sponsors and cross-functional teams.

The position requires 10+ years in pharma/CRO regulatory roles, strong EU/GCP/ICH expertise, and experience coordinating US/Canada submissions.

Qualifications

• Minimum 10 years pharmaceutical or CRO regulatory experience.
• Strong knowledge of EU regulations, GCP and ICH guidelines.
• Experience coordinating regulatory submissions across US/Canada and other regions.

Responsibilities

• Provide day-to-day line management for Regulatory Specialists and Coordinators.
• Oversee regulatory document processes and study start-up timelines.
• Monitor staffing, timelines, and risks across multiple studies and countries.
• Coordinate cross-functional teams to ensure timely, inspection-ready submissions.
• Develop and update regulatory SOPs and drive process improvements.
• Provide regulatory education and training on ICH, GCP, and applicable requirements.

Skills

Regulatory leadership

Cross-country oversight

EU regulations

GCP/ICH knowledge

US/Canada submissions

Education

Bachelor’s degree in health-related field

Job description

CTI Clinical Trial and Consulting Services seeks a Regulatory Affairs Study Start-Up Manager to lead regulatory teams and ensure timely, compliant start-up activities across multiple studies and countries. The role emphasizes coaching, process improvements, and collaboration with sponsors and cross-functional teams.

The position requires 10+ years in pharma/CRO regulatory roles, strong EU/GCP/ICH expertise, and experience coordinating US/Canada submissions.