Senior Regulatory Start-Up Manager, Regional Oversight

CTI Clinical Trial and Consulting Services; Covington (KY); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Hybrid work

Tuition reimbursement

Leadership courses

Mentoring program

Job summary

CTI Clinical Trial and Consulting Services seeks a Regulatory Affairs Study Start-Up Manager to lead Regulatory Specialists and Coordinators across multiple studies. You will oversee regulatory timelines, ensure compliant, inspection-ready study execution, and provide coaching and development.

This role is office-based at our Covington, KY headquarters or our Raleigh, NC office, with regional oversight and collaboration with sponsors and cross-functional teams to drive timely submissions and

Qualifications

• Bachelor’s Degree in allied health field or equivalent experience.
• At least 10 years pharmaceutical or CRO Clinical Regulatory experience.
• Strong knowledge of EU regulations, GCP, ICH guidelines.
• Experience with central and local regulatory submissions US/Canada; LATAM preferred.

Responsibilities

• Provide day-to-day line management for Regulatory Specialists and Regulatory Coordinators.
• Coach and mentor team members to strengthen technical and leadership capabilities and professional development.
• Oversee regulatory document processes and study-specific regulatory timelines; monitor progress and compliance.
• Assess study-specific regulatory resource needs and establish appropriate teams.
• Ensure regulatory milestones are achieved and study maintenance activities are completed.
• Coordinate support for studies with critical timelines and ensure coverage during absences.
• Contribute regulatory expertise to new business proposals and bid defenses.
• Provide education on ICH guidelines, GCP, and regulatory requirements.
• Maintain knowledge of national/international regulatory requirements and their impact on study start-up.
• Represent Regulatory Affairs in meetings and communicate status updates and risks.
• Lead internal regulatory team meetings to align priorities and drive decisions.
• Monitor SSU and eTMF status and ensure records are inspection-ready.
• Oversee QA/QC reviews of regulatory documents and reports.
• Develop and update SOPs and lead continuous improvement of regulatory processes.
• Provide hands-on Regulatory Specialist support when required.

Skills

Regulatory leadership

Cross-country coordination

Regulatory strategy

GCP/ICH knowledge

Project management

Education

Bachelor’s Degree in allied health

Job description

CTI Clinical Trial and Consulting Services seeks a Regulatory Affairs Study Start-Up Manager to lead Regulatory Specialists and Coordinators across multiple studies. You will oversee regulatory timelines, ensure compliant, inspection-ready study execution, and provide coaching and development.

This role is office-based at our Covington, KY headquarters or our Raleigh, NC office, with regional oversight and collaboration with sponsors and cross-functional teams to drive timely submissions and