Madrid: Regulatory Submissions Coordinator, Clinical Trials

Medpace; Madrid; On-site; EUR 30,000 - 42,000; Full time

Job summary

Medpace is seeking a Regulatory Submissions Coordinator in Madrid, Spain, to join our Clinical Operations team. This office-based role focuses on preparing, reviewing, and filing regulatory submissions to Ethics Committees and Regulatory Agencies, while ensuring compliance with applicable guidelines.

Fluency in Spanish and English is required, and prior CRO/pharma experience is preferred. You will maintain essential documents, support queries, and help keep the clinical trial management system

Qualifications

• Bachelor's degree required (Life Sciences preferred).
• Minimum 1 year preparing, reviewing, and submitting regulatory docs.
• Experience at a CRO, pharma company, or investigative site.
• Excellent organizational and prioritization abilities.
• Fluent in Spanish and English; strong written and verbal communication.

Responsibilities

• Prepare, review, and file initial regulatory submissions to authorities.
• Prepare and submit responses to queries and amendments.
• Ensure submissions comply with regulations and guidelines.
• Advise on changes to regulations and compliance.
• Maintain the Clinical Trial Management System and file timeliness.
• Collect essential documents and prepare document packages for drug release.

Skills

Fluency in Spanish and English

Organizational skills

Prioritization

Independent work

Communication skills

Education

Bachelor's degree (Life Sciences preferred)

Tools

Microsoft Office

Job description

Medpace is seeking a Regulatory Submissions Coordinator in Madrid, Spain, to join our Clinical Operations team. This office-based role focuses on preparing, reviewing, and filing regulatory submissions to Ethics Committees and Regulatory Agencies, while ensuring compliance with applicable guidelines.

Fluency in Spanish and English is required, and prior CRO/pharma experience is preferred. You will maintain essential documents, support queries, and help keep the clinical trial management system