Clinical Trial Regulatory Coordinator: Site Submissions

Fortrea; Manila; On-site; PHP 360,000 - 480,000; Full time

Job summary

Fortrea is seeking a Regulatory Submissions Specialist to act as the primary contact for investigative sites, ensuring collection of essential documents and timely submission to IRB/IEC and regulatory authorities. The role supports in-country submissions, coordination with vendors, and maintenance of study documentation to remain audit-ready.

Responsibilities include compiling submission packages, updating study documents, and assisting with CTIS uploads under supervision.

Qualifications

• University/College degree (life science preferred), or certification in a related allied health profession.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Responsibilities

• Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
• Assist in compiling, preparing, submitting, and obtaining approval of submission documents to IRB/IEC/Third body/Regulatory Authority.
• Update status reports and documents to ensure Fortrea readiness for audits.
• Upload submission documentation to CTIS under supervision.

Skills

ICH/GCP knowledge

Regulatory submissions

Education

Life science degree or related certification

Job description

Fortrea is seeking a Regulatory Submissions Specialist to act as the primary contact for investigative sites, ensuring collection of essential documents and timely submission to IRB/IEC and regulatory authorities. The role supports in-country submissions, coordination with vendors, and maintenance of study documentation to remain audit-ready.

Responsibilities include compiling submission packages, updating study documents, and assisting with CTIS uploads under supervision.