Experteer Overview

In this role you will manage regulatory submissions end-to-end to support clinical trials in Spain. You will work within Clinical Operations to prepare and file initial regulatory applications, respond to queries, and ensure compliance with guidelines.

You will maintain the Clinical Trial Management System and assemble essential document packages for drug releases. This is an office-based Madrid position with growth opportunities guiding regulatory strategy and cross-functional collaboration.

Compensaciones / Ventajas

- Prepare, review, and file initial clinical trial applications to regulatory authorities
- Prepare and submit responses to queries and amendments to clinical trial applications
- Ensure 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 documents packages for drug release

Responsabilidades

- Bachelor's degree
- Experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies (including formulating responses to queries)
- Relevant working experience at a CRO, pharmaceutical company, or investigative site
- Knowledge of regulatory guidelines
- Excellent organizational and prioritization skills
- Independent with a proactive approach
- Knowledge of Microsoft Office
- Fluency in Spanish and English
- Attention to detail and strong oral and written communication skills

Requisitos principales

- Competitive compensation
- Health, wellness, retirement, and PTO benefits
- Office-based culture with occasional WFH after training
- On-site mentors
- Industry onboarding and training programs
- Opportunities for professional development

📌 Regulatory Submissions (Study Start Up) Coordinator (Madrid)
🏢 Medpace
📍 Madrid