Global Site Start-Up & Regulatory Specialist

FTMEX Fortrea Clinical Development Mexico S.DeR.L.DeC.V.; Ciudad de México; Sur place; MXN 700 000 - 950 000; Plein temps

Résumé du poste

Fortrea is seeking a Regulatory Start-up Specialist to act as the local expert for site activation and regulatory submissions. You will collect essential documents, prepare country applications, and liaise with EC/IRB/Regulatory Authorities to meet timelines and sponsor requirements.

The role requires 2+ years in clinical research with strong ICH/RA/IRB knowledge and the ability to train less-experienced colleagues. Office-based in Mexico City with cross-country coordination.

Qualifications

• University/College degree (life science preferred) or related allied health certification and 2 years' clinical research experience with knowledge of ICH guidelines and RA/IRB/IEC regulations.
• Alternative: High School Diploma with 2 years' clinical research experience including ICH RA/IRB/IEC regulations.

Responsabilités

• Maintain awareness of regulatory legislation, guidance, and practice in assigned countries.
• Coordinate, collect and organize data required by EC/IRB/Third body/Regulatory Authority including country application forms and cover letters.
• Prepare study documentation (e.g., INDs/CTAs) and liaise with Regulatory Authorities for submission/approval.
• Review final submission documents and ensure start-up and maintenance activities are on track and compliant with laws and guidelines.
• Serve as primary contact for investigative sites and provide training/mentoring as needed.
• Assist in strategy definitions for Site Activation and provide timelines to study teams.

Connaissances

ICH guidelines knowledge

Regulatory Affairs knowledge

IRB/IEC regulations

Site start-up documentation

Contract/budgets negotiation

Formation

University/College degree (life science preferred)

High School Diploma + 2 years clinical research experience

Description du poste

Fortrea is seeking a Regulatory Start-up Specialist to act as the local expert for site activation and regulatory submissions. You will collect essential documents, prepare country applications, and liaise with EC/IRB/Regulatory Authorities to meet timelines and sponsor requirements.

The role requires 2+ years in clinical research with strong ICH/RA/IRB knowledge and the ability to train less-experienced colleagues. Office-based in Mexico City with cross-country coordination.