[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

• Competitive compensation programs that recognize and reward performance;
• Comprehensive health, wellness, retirement, and PTO benefits;
• Office based culture with occasional WFH that provides flexibility for eligible positions after training;
• Company-sponsored social events;
• Please note benefits may vary based on country.