Regulatory Clinical Trial Submissions Coordinator

Fortrea; Manila; On-site; PHP 280,000 - 520,000; Full time

Job summary

Fortrea in Manila is seeking a Regulatory Submissions Associate to act as primary contact for investigative sites during study maintenance and site start-up activities. You will collect essential documents, ensure timely submissions to IRB/IEC/Regulatory authorities, and support preparation under guidance of senior staff.

The role requires a life science degree (or related certification) and 0–2 years of experience, with working knowledge of ICH/GCP and regulatory guidelines.

Qualifications

• University degree in life science or related allied health certification.
• 0–2+ years of regulatory or clinical trial experience.
• Solid understanding of ICH, RA, IRB/IEC guidelines.

Responsibilities

• Serve as primary contact for investigative sites during study maintenance.
• Assist in compiling, submitting, and obtaining approvals for regulatory docs.
• Liaise with vendors and perform quality review of submissions.
• Ensure compliance with ICH/GCP, SOPs, and local regulatory requirements.

Skills

Regulatory submissions coordination

ICH/GCP knowledge

IRB/IEC familiarity

Vendor coordination

Documentation management

Education

Bachelor's degree in Life Science

Certification in allied health profession

Job description

Fortrea in Manila is seeking a Regulatory Submissions Associate to act as primary contact for investigative sites during study maintenance and site start-up activities. You will collect essential documents, ensure timely submissions to IRB/IEC/Regulatory authorities, and support preparation under guidance of senior staff.

The role requires a life science degree (or related certification) and 0–2 years of experience, with working knowledge of ICH/GCP and regulatory guidelines.