Experienced Regulatory Submissions Coordinator

Job Summary

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Coordinator to join our Clinical Operations team. This position plays a key role in the clinical trial management process at Medpace.

Responsibilities

• Provide day-to-day departmental support activities to Regulatory Submissions Coordinators;
• Maintain database and spreadsheets as necessary to facilitate tracking and documentation of departmental activities;
• Collect, review, organize, and assemble regulatory start-up submissions;
• Perform other tasks as needed;
• Prepare, review, and file clinical trial applications;
• Communicate with research sites (hospitals, etc.) to collect all essential documents required before the site starts to enrol patients to participate in the clinical trial;
• Provide insightful input on regulatory submissions documents and maintain timelines for study start-up through both internal and external collaboration;
• Ensure submissions comply with applicable regulations and guidance documents.

Qualifications

• Bachelor's degree in a Life Sciences field;
• 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.

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.

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