Regulatory Start-Up Specialist - Clinical Trials

Fortrea; Ciudad de México; Presencial; MXN 300.000 - 420.000; Jornada completa

Descripción de la vacante

Fortrea is seeking a regulatory affairs professional to support study maintenance and site startup activities, ensuring investigator and regulatory documents meet EC/IRB/Regulatory Authority timelines. With guidance from senior staff, you will develop awareness of applicable regulatory legislation and guidance in assigned countries.

You will assist in compiling, submitting, and obtaining approvals for submission documents, liaising with vendors, and performing quality reviews to ensure readiness

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.

Responsabilidades

• Develop awareness of regulatory legislation, guidance, and practice in the assigned countries with the support from senior staff.
• Assist senior staff to compile, prepare, submit, and obtain approval of the submission documents to IRB/IEC/Third body/Regulatory Authority in accordance with local requirements.
• Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).
• Perform a review of final submission documents as applicable.
• Organize communication related to the submissions/outcomes within Fortrea as applicable.

Conocimientos

Regulatory knowledge

Clinical trial process understanding

Educación

University/College degree (life science preferred)

Descripción del empleo

Fortrea is seeking a regulatory affairs professional to support study maintenance and site startup activities, ensuring investigator and regulatory documents meet EC/IRB/Regulatory Authority timelines. With guidance from senior staff, you will develop awareness of applicable regulatory legislation and guidance in assigned countries.

You will assist in compiling, submitting, and obtaining approvals for submission documents, liaising with vendors, and performing quality reviews to ensure readiness