Global Regulatory Start-Up Lead

CTI; Covington (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

CTI Clinical Trial and Consulting Services in Covington, NC seeks a Regulatory Documentation Specialist to manage essential regulatory documentation for global clinical studies and coordinate submissions with IRBs, ECs, and authorities.

You will review study documents, ensure compliance by country requirements, assist project teams, and maintain TMF and submission packages across sites.

Qualifications

• Associate’s or Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience.
• 3–5 years of regulatory/pharma experience.

Responsibilities

• Assist project teams on regulatory requirements for clinical studies.
• Perform country-specific regulatory compliance assessments and report findings.
• Review study documents for country/site requirements.
• Submit IRB/EC approvals on behalf of sponsors/sites per country rules.
• Compile regulatory documentation and conduct QA checks before submissions.

Skills

Regulatory experience

Cross-functional collaboration

Documentation management

Education

Degree in allied health

Job description

CTI Clinical Trial and Consulting Services in Covington, NC seeks a Regulatory Documentation Specialist to manage essential regulatory documentation for global clinical studies and coordinate submissions with IRBs, ECs, and authorities.

You will review study documents, ensure compliance by country requirements, assist project teams, and maintain TMF and submission packages across sites.