Experienced Regulatory Submissions Coordinator

Overview

In this Regulatory Submissions Coordinator role, you support the clinical operations team to drive start-up activities and ensure compliant submissions. You will manage documentation, coordinate with research sites, and maintain timelines across study start-up. You’ll contribute to efficient regulatory processes and cross-functional collaboration. This is a growth-focused opportunity with hands-on regulatory experience at a leading CRO.

Pay / Benefits

• Flexible work environment
• Competitive compensation and benefits package
• Competitive PTO packages
• Structured career paths with opportunities for professional growth
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives

Responsibilities

• Provide day-to-day departmental support to Regulatory Submissions Coordinators
• Maintain database and spreadsheets to track activities and documentation
• Collect, review, organize, and assemble regulatory start-up submissions
• Prepare, review, and file clinical trial applications
• Communicate with research sites to collect essential documents before site enrolment
• Provide input on regulatory submissions and maintain study start-up timelines
• Ensure submissions comply with applicable regulations and guidance documents

Key requirements

• Bachelors degree in Life Sciences
• At least 2 years of work experience as a Regulatory Submissions Coordinator
• Hands-on experience preparing, reviewing, and submitting regulatory documentation
• Knowledge of Microsoft Office
• Excellent organization and communication skills
• Great attention to detail
• organization
• communication
• detail-oriented
• regulatory documentation preparation
• regulatory submissions process
• document management

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