Regulatory Submissions Associate - Clinical Start-Up

Fortrea; Buenos Aires; On-site; ARS 1,200,000 - 2,000,000; Full time

Job summary

Fortrea is seeking a Regulatory Affairs professional to act as the primary site liaison, ensuring timely collection and submission of essential documents for EC/IRB/Regulatory Authority approvals. You will support in-country regulatory activities, maintain compliant study documentation, and coordinate with vendors to meet global requirements.

Experience with ICH/GCP, regulatory guidelines, and CTIS submissions is preferred.

Qualifications

• University/College degree in life sciences or related field.
• Experience in regulatory submissions and document preparation.
• Knowledge of ICH, GCP, and regulatory guidelines.
• Ability to work with cross-country teams and stakeholders.

Responsibilities

• Serve as primary contact for investigative sites and collect required documents.
• Assist submission of documents to IRB/IEC/Regulatory Authority and obtain approvals.
• Coordinate with internal/external vendors for regulatory submissions and document quality reviews.
• Review final submission documents for accuracy and compliance.
• Maintain documentation and status updates for audits and regulatory tracking.
• Support CTIS submissions under supervision and adapt materials as needed.
• Escalate risks to Submission Leads and manage cross-country regulatory timelines.
• Perform other duties as assigned by management.

Skills

Regulatory submissions

Clinical trial knowledge

Documentation control

Communication

Quality review

Education

Bachelor's degree in life sciences

Tools

CTIS system

IRB/IEC processes

Job description

Fortrea is seeking a Regulatory Affairs professional to act as the primary site liaison, ensuring timely collection and submission of essential documents for EC/IRB/Regulatory Authority approvals. You will support in-country regulatory activities, maintain compliant study documentation, and coordinate with vendors to meet global requirements.

Experience with ICH/GCP, regulatory guidelines, and CTIS submissions is preferred.