Regulatory Submissions Coordinator

Job Summary

Our clinical activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Specialist to join our Clinical Operations team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

• Prepare, review, and file clinical trial applications to domestic and international regulatory agencies;
• Ensure submissions comply with applicable regulations and guidance documents;
• Advise sponsors on changing regulations and compliance requirements;
• Track submissions and ensure timely filing of documents.

Qualifications

• Minimum Bachelor's degree in Life Sciences
• Experience as a Regulatory Submissions Coordinator for EC/RA applications in Italy
• Excellent organization and communication skills
• Knowledge of Microsoft® Office
• Hands-on experience preparing, reviewing, and submitting regulatory documentation
• Fluent in Italian and English.

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Why Medpace?

When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.