Regulatory Submissions Coordinator

Responsibilities

• Prepare, review, and file initial clinical trial applications to regulatory authorities
• Prepare and submit responses to queries and amendments to clinical trial applications
• Ensure all submissions comply with applicable regulations and guidance documents
• Advise team members on changing regulations and compliance requirements
• Maintain the Clinical Trial Management System and ensure timely filing of documents
• Collect essential documents and prepare essential document packages for drug release

Requirements

• Bachelor's degree in Life Sciences or a related field
• Experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies
• Previous working experience at a CRO, Pharmaceutical Company, or an investigative site
• Strong knowledge of regulatory guidelines
• Fluency in both Spanish and English
• Proficiency in Microsoft Office
• Excellent organizational, prioritization, and communication skills

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
• Employee health 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. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach. Headquartered in Cincinnati, Ohio, Medpace employs more than 6,000 people across 40+ countries.