Regulatory Submissions (Study Start Up) Coordinator

Medpace; Madrid; Sur place; EUR 30 000 - 42 000; Plein temps

Résumé du poste

Medpace is seeking a Regulatory Submissions Coordinator in Madrid, Spain, to join our Clinical Operations team. This office-based role focuses on preparing, reviewing, and filing regulatory submissions to Ethics Committees and Regulatory Agencies, while ensuring compliance with applicable guidelines.

Fluency in Spanish and English is required, and prior CRO/pharma experience is preferred. You will maintain essential documents, support queries, and help keep the clinical trial management system

Qualifications

• Bachelor's degree required (Life Sciences preferred).
• Minimum 1 year preparing, reviewing, and submitting regulatory docs.
• Experience at a CRO, pharma company, or investigative site.
• Excellent organizational and prioritization abilities.
• Fluent in Spanish and English; strong written and verbal communication.

Responsabilités

• Prepare, review, and file initial regulatory submissions to authorities.
• Prepare and submit responses to queries and amendments.
• Ensure submissions comply with regulations and guidelines.
• Advise on changes to regulations and compliance.
• Maintain the Clinical Trial Management System and file timeliness.
• Collect essential documents and prepare document packages for drug release.

Connaissances

Fluency in Spanish and English

Organizational skills

Prioritization

Independent work

Communication skills

Formation

Bachelor's degree (Life Sciences preferred)

Outils

Microsoft Office

Description du poste

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);
• At least 1 year 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;
• 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 global development of safe and effective medical therapeutics through the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.

Why Medpace?

When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.

Purpose-Driven Work

• Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

Collaborative Culture

• Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
• Leadership throughout Medpace is both accessible and approachable

Continuous Growth & Development

• Office based environment with on-site mentors
• Defined career paths with clear advancement opportunities
• Industry renowned onboarding and training programs designed to accelerate professional development
• Ongoing training and continuous learning opportunities throughout your career
• An environment that encourages employees to influence change, contribute ideas, and grow quickly

Other Employee Benefits

• Competitive compensation programs that recognize and reward performance
• Comprehensive health, wellness, retirement, and PTO benefits
• Office based culture with occasional WFH that provides flexibility for eligible positions after training
• Company-sponsored social events

Please note benefits may vary based on country.

What To Expect Next

A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.