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);
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 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 effective medical therapeutics through the

📌 Regulatory Submissions (Madrid)
🏢 Medpace
📍 Madrid