Site Activation & Regulatory Start-Up Expert

Fortrea; Paris; On-site; EUR 50,000 - 70,000; Full time

Job summary

Fortrea is seeking an experienced Regulatory Start-Up professional to manage site activation documentation and submissions across assigned countries. You will coordinate regulatory data, liaise with IRB/IEC and authorities, and mentor junior colleagues as needed.

The role emphasizes ICH guidelines, RA/IRB/IEC regulations, and collaboration with project teams to ensure on-time submissions and compliant activations.

Qualifications

• University/College degree in life sciences and 2 years' work experience in clinical research with knowledge of ICH guidelines and RA/IRB/IEC regulations.
• Fortrea may consider equivalent experience in lieu of educational requirements.
• High School Diploma or equivalent with 2 years' clinical research experience and knowledge of ICH/RA/IRB/IEC regulations will be considered.

Responsibilities

• Maintain awareness of regulatory legislation, guidance, and practice in the assigned countries.
• Coordinate, collect and organize data needed by regulatory authorities for country submissions.
• Compile and prepare routine submissions for IRB/IEC/Third body submissions and liaise with them as applicable.
• Liaise with internal and external vendors for regulatory submissions.
• Review final submission documents for accuracy and compliance.
• Ensure start-up and maintenance activities are on track per client expectations, budget, and laws.
• Proactively identify and prevent study issues and escalate as needed.
• Support in country activation strategy and timelines with study teams.

Skills

Regulatory knowledge

Clinical research

Documentation quality

Education

Bachelors in life sciences

High School Diploma + 2 years clinical research

Job description

Fortrea is seeking an experienced Regulatory Start-Up professional to manage site activation documentation and submissions across assigned countries. You will coordinate regulatory data, liaise with IRB/IEC and authorities, and mentor junior colleagues as needed.

The role emphasizes ICH guidelines, RA/IRB/IEC regulations, and collaboration with project teams to ensure on-time submissions and compliant activations.