Regulatory Submissions Coordinator

Responsibilities

• Perform required activities to lead to the activation of investigative sites in all phases of clinical trials
• Prepare, review, and submit documents to Regulatory Agencies (MFDS) and Ethics Committees
• Review and finalize essential documents required for site activation
• Act as a primary contact for ethical and regulatory submission-related activities
• Maintain direct contact with investigative sites during the study start-up and activation process
• Ensure all submissions comply with applicable regulations and guidance documents
• Track submissions and ensure the timely filing of all necessary documentation

Requirements

• Bachelor's degree in Pharmacy or an equivalent combination of education and experience
• Excellent English communication skills
• Proficiency with Microsoft Office
• Knowledge of ICH-GCP guidelines and regulatory guidelines
• Strong organizational skills and a proactive approach to learning

Preferred Qualifications

• Advanced education such as a Master's or PhD
• Knowledge in gene therapy, advanced therapies, or related fields

Benefits

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

About the Company

Medpace is a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Headquartered in Cincinnati, Ohio, Medpace employs more than 6,000 people across 40+ countries, leveraging local regulatory and therapeutic expertise to accelerate the global development of safe and effective medical therapeutics.