Global Regulatory Start-Up Specialist

CTI Clinical Trial and Consulting Services; Raleigh (NC); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health benefits

Vacation packages

Hybrid work from home opportunities

Paid parental leave

Job summary

CTI Clinical Trial and Consulting Services seeks a Regulatory Documentation Specialist to manage essential regulatory documentation, assist study teams, and ensure compliance with country requirements across multiple studies. This role requires coordination with sponsors, sites, and CTI management to provide timely status reports and maintain archival quality.

The ideal candidate will have a degree in allied health and 3–5 years of relevant regulatory experience in pharma/CRO settings, with

Qualifications

• Associate’s or Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience.
• A minimum of 3 - 5 years of relevant pharmaceutical, site, or CRO Regulatory experience.

Responsibilities

• Assist project teams on regulatory requirements for clinical studies
• Perform compliance assessments per country requirements and report findings
• Review study documents per country/site requirements
• Submit IRB/EC/CA submissions for sponsors/sites per country requirements
• Receive and process study documentation from sites; check content and quality
• Assist with preparation for Sponsor or Agency audits and inspections

Skills

Regulatory experience

Documentation management

IRB submissions

Education

Associate’s or Bachelor’s degree in allied health

Job description

CTI Clinical Trial and Consulting Services seeks a Regulatory Documentation Specialist to manage essential regulatory documentation, assist study teams, and ensure compliance with country requirements across multiple studies. This role requires coordination with sponsors, sites, and CTI management to provide timely status reports and maintain archival quality.

The ideal candidate will have a degree in allied health and 3–5 years of relevant regulatory experience in pharma/CRO settings, with