Regulatory Submissions & Startup Associate

FTARG Fortrea Argentina S.A.; Buenos Aires; On-site; ARS 1,200,000 - 2,100,000; Full time

Job summary

Fortrea Argentina S.A. seeks a Regulatory Submissions Specialist to coordinate the preparation and submission of regulatory documents for IRB/IEC regulatory authorities, with guidance from senior staff.

The role includes liaising with vendors, reviewing final submission packages, and ensuring timely site activation and maintenance. The candidate will support in-country and global activities, adapt informed consent forms to country requirements, and may assist in contract negotiations under

Qualifications

• 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.

Responsibilities

• Assist senior staff to compile, prepare, submit, and obtain approval of 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.
• Perform a review of final submission documents; organize communication related to submissions/outcomes within Fortrea.
• Update study documents when there are changes in study personnel/study amendments.
• Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
• Quality review, formatting, and compilation of final documents for site activation and maintenance.

Education

University/College degree (life science preferred)

Job description

Fortrea Argentina S.A. seeks a Regulatory Submissions Specialist to coordinate the preparation and submission of regulatory documents for IRB/IEC regulatory authorities, with guidance from senior staff.

The role includes liaising with vendors, reviewing final submission packages, and ensuring timely site activation and maintenance. The candidate will support in-country and global activities, adapt informed consent forms to country requirements, and may assist in contract negotiations under