Global Regulatory Submissions & Site Activation Associate

FTMEX Fortrea Clinical Development Mexico S.DeR.L.DeC.V.; Ciudad de México; Presencial; MXN 420.000 - 520.000; Jornada completa

Descripción de la vacante

Fortrea Clinical Development Mexico seeks a Regulatory Submissions Specialist to liaise with investigative sites during study maintenance and startup activities. You will collect essential documents to support submissions and ensure they are submitted within project timelines, under guidance from senior staff.

You will assist in compiling, reviewing, and obtaining approvals from IRB/IEC/Regulatory Authority, liaise with vendors, and adapt patient-facing materials to country-specific

Formación

• University/College degree (life science preferred) or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology). Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Experience with regulatory submissions processes and ICH/GCP guidelines is preferred.

Responsabilidades

• Serve as primary contact for investigative sites during study maintenance and site startup activities.
• Assist in compiling, submitting, and obtaining approval of submission documents to IRB/IEC/Third body/Regulatory Authority.
• Coordinate with internal and external vendors for regulatory submissions and perform quality reviews of submission documents.
• Maintain and update study documents and status reports; adapt informed consent forms to country-specific requirements.

Educación

University/College degree (life science preferred)

Descripción del empleo

Fortrea Clinical Development Mexico seeks a Regulatory Submissions Specialist to liaise with investigative sites during study maintenance and startup activities. You will collect essential documents to support submissions and ensure they are submitted within project timelines, under guidance from senior staff.

You will assist in compiling, reviewing, and obtaining approvals from IRB/IEC/Regulatory Authority, liaise with vendors, and adapt patient-facing materials to country-specific