Regulatory Start-Up Manager — Global Trials

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

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.