Regulatory Submissions (Study Start Up) Coordinator

Medpace; Madrid; Presencial; EUR 40.000 - 55.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible work environment

Competitive compensation and benefits package

Structured career paths with opportunities for professional growth

Company-sponsored employee appreciation events

Employee health and wellness initiatives

Descripción de la vacante

A leading clinical contract research organization is seeking a Regulatory Submissions Coordinator in Madrid. This key role involves preparing and filing clinical trial applications, ensuring compliance with regulations, and advising on regulatory requirements. Candidates should have a Bachelor’s degree in Life Sciences, experience in regulatory documentation, and be fluent in both Spanish and English. The position offers a flexible work environment and competitive compensation along with numerous professional growth opportunities.

Formación

• Bachelor's degree required, preferably in a Life Sciences field.
• Experience with regulatory documentation preparation.
• Relevant experience at a CRO or Pharmaceutical Company.
• Knowledge of regulatory guidelines is essential.

Responsabilidades

• Prepare and file clinical trial applications.
• Submit responses to queries from regulatory authorities.
• Advise team members on compliance requirements.
• Maintain Clinical Trial Management System documentation.

Conocimientos

Organizational skills

Prioritization skills

Regulatory knowledge

Proactive approach

Fluency in Spanish

Fluency in English

Attention to detail

Written communication skills

Oral communication skills

Educación

Bachelor's degree in Life Sciences

Herramientas

Microsoft Office

Descripción del empleo

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). We provide Phase I–IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global 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 future.

Medpace Perks

• Flexible work environment
• Competitive compensation and benefits package
• Competitive PTO packages
• Structured career paths with opportunities for professional growth
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives

Awards

• Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What To Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.