Regulatory Submissions Coordinator

Medpace, Inc.; München; Presencial; EUR 42.000 - 62.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health benefits

Career development

On-site mentors

Team events

Descripción de la vacante

Medpace is seeking a Regulatory Submissions Coordinator for our Clinical Operations team in Munich. The role focuses on preparing and filing regulatory submissions for Germany, Austria, and Switzerland, coordinating with research sites, and ensuring compliance with evolving regulations.

The ideal candidate will have a life sciences degree, strong German and English skills, and a passion for drug development and clinical trials. Office-based position with opportunities for growth.

Formación

• Bachelor's degree in Life Sciences.
• Interest in drug development and clinical trials.
• Proficiency in German and English, written and verbal.
• Knowledge of Microsoft Office.
• Excellent organization and communication skills.

Responsabilidades

• Prepare, review, and file regulatory submissions for Germany, Austria and Switzerland (DACH).
• Coordinate with clinical sites across DACH to gather required documents.
• Provide input on regulatory submissions documents and maintain study start-up timelines.
• Ensure compliance with applicable regulations and guidance documents.
• Advise on changing country regulations and compliance requirements.
• Track submissions and ensure timely filing of documents.

Conocimientos

German & English proficiency

Microsoft Office

Organization skills

Communication skills

Educación

Bachelor's degree in Life Sciences

Descripción del empleo

Job Summary

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time office-based Regulatory Submissions Coordinator to join our Clinical Operations team in Munich. This position plays a key role in the clinical trial management process at Medpace. 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.

Entry-level positions with permanent contract are available for recent graduates.

Responsibilities

• Prepare, review, and file clinical trial applications for Germany, Austria and Switzerland (DACH);
• Communicate with research sites in Germany, Austria and Switzerland (hospitals, etc.) to collect all essential documents required before the site starts to enroll patients to participate in the clinical trial;
• Provide insightful input on regulatory submissions documents and maintain timelines for study start-up through both internal and external collaboration;
• Ensure submissions comply with applicable regulations and guidance documents;
• Advise on changing country regulations and compliance requirements; and
• Track submissions and ensure timely filing of documents.

Qualifications

• Bachelor's degree (preferably in a Life Sciences field);
• Interest in drug development and clinical trials;
• Full professional proficiency in German and English in written and verbal communication;
• Knowledge of Microsoft Office; and
• Excellent organization and communication skills,great attention to detail.

Travel: None

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.