Regulatory Submissions Coordinator
About the role
Medpace is hiring a full-time office-based Regulatory Submissions Coordinator to join the Clinical Operations team in Munich and support clinical trial management.
The position is suitable for candidates who want to apply and further develop previous expertise; entry-level positions with permanent contracts 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.
- Track submissions and ensure timely filing of documents.
Requirements
- 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.
- We kindly ask to submit applications in English and to indicate the status of your work permit if needed.
Skills
- German and English — full professional proficiency in written and verbal communication.
- Microsoft® Office — working knowledge.
- Strong organisation and communication skills, with great attention to detail.
Work arrangement
Full-time, office-based role in Munich.
Benefits
- Career development: office-based mentors, defined career paths, renowned onboarding, and ongoing training.
- Additional benefits: competitive compensation, comprehensive health/wellness/retirement/PTO benefits, occasional WFH flexibility for eligible positions after training, and company social events (benefits may vary by country).
Company context
Medpace is a full-service clinical CRO providing phase I–IV clinical development services to biotechnology, pharmaceutical and medical device industries; headquartered in Cincinnati, Ohio, with more than 6,500 employees across 40+ countries.
Medpace emphasises purpose-driven work, collaborative culture and continuous growth and development, with opportunities to work alongside physicians and scientists and accessible leadership.
Relevant source disclaimer
A Medpace team member will review your application; if your profile matches current needs you will be contacted for an interview, and only candidates selected for interviews will be contacted.