[Hiring] Regulatory Submissions Coordinator @Medpace, Inc.

Role Description

Our clinical activities are growing rapidly, and we are currently seeking a full-time home-based Regulatory Submissions Coordinator. 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.

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

Qualifications

• Minimum Bachelor's degree in life sciences;
• At least one year of work experience as a Regulatory Submissions Coordinator for European regulation (CTR);
• Excellent organization and communication skills;
• Knowledge of Microsoft® Office;
• Hands-on experience preparing, reviewing, and submitting regulatory documentation;
• Greek (mother tongue) and very good knowledge of English.

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.

Company Description

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 6,000 people across 40+ countries.