Job Summary
Our clinical operations activities are growing rapidly, and we are currently seeking a Regulatory Submissions Coordinator to join our Clinical Operations team in Spain. This position plays a key role in the clinical trial management process at Medpace. Please note that this is an office-based position in Madrid . 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.
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 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;
- Collection of essential documents and preparation essential documents packages for drug release.

Qualifications




- A minimum of a Bachelor's degree is required (preferably in a Life Sciences field);
- Experiencepreparing, 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 an investigative site;
- Knowledge of regulatory guidelines
- Excellent organizational and prioritization skills;
- Use to work independently with a proactive approach;
- Knowledge of Microsoft Office;
- Fluency in Spanish and English;
- Great attention to detail and excellent oral and written communication skills.

We kindly ask to submit applications in English.
Medpace Overview
Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the general development of safe and effe

📌 Regulatory Submissions (Madrid)
🏢 Medpace
📍 Madrid