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 anoffice-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.ResponsibilitiesPrepare, 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.QualificationsA 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 organizationaland 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 dpace OverviewMedpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV 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 its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.Why Medpace?People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the dpace PerksFlexible work environmentCompetitive compensation and benefits packageCompetitive PTO packagesStructured career paths with opportunities for professional growthCompany-sponsored employee appreciation eventsEmployee health and wellness initiativesAwardsRecognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibilityWhat to Expect NextA Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

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