Experienced Regulatory Submissions
vor 1 Woche
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. Job Summary As a Regulatory Submissions Coordinator you will have the opportunity to work within Regulatory Submissions, supporting our many projects and gaining some vital experience. You will be a productive member of the team office-based in Munich , and will be mentored and supported as you develop your skills. Working directly with Regulatory Submissions Coordinators, you will gain valuable hands-on experience to enable you to develop a career in clinical research. Responsibilities Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees in Germany, Austria and Switzerland; 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 in DACH region; Excellent organizational and prioritization skills; Use to work independently with a proactive approach; Knowledge of Microsoft Office; Fluency in German and English; Great attention to detail and excellent oral and written communication skills. We kindly ask to submit applications in English.
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Regulatory Submissions Coordinator
vor 2 Wochen
München, Deutschland Medpace, Inc. VollzeitJob 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...
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Regulatory Affairs Manager
Vor 5 Tagen
München, Deutschland Cpl Life Sciences Vollzeitob Title: European Regulatory Affairs Manager Location: Munich, Germany - Hybrid, 3x a week in the office Remuneration: Competitive salary and package Regulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is increasingly growing and is looking for a...
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Regulatory Officer
vor 3 Wochen
München, Deutschland PSI CRO Deutschland GmbH VollzeitCompany DescriptionPSI is a leading Contract Research Organization with almost 30 years on the market, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Regulatory Officer Munich, Germany I Full-time Job DescriptionJoin...
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Regulatory Officer
vor 4 Wochen
München, Deutschland PSI CRO Deutschland GmbH VollzeitCompany Description PSI is a leading Contract Research Organization with almost 30 years on the market, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Regulatory OfficerMunich, Germany I Full-time Job Description Join...
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Regulatory Officer
vor 3 Wochen
München, Deutschland PSI CRO Deutschland GmbH VollzeitCompany Description PSI is a leading Contract Research Organization with almost 30 years on the market, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Regulatory Officer Munich, Germany I Full-time Job Description Join...
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Senior Manager/Director of Regulatory Affairs
Vor 5 Tagen
München, Deutschland Cpl Life Sciences Vollzeitob Title: European Regulatory Affairs Manager Location: Munich, Germany - Hybrid, 3x a week in the office Remuneration: Competitive salary and package Regulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is increasingly growing and is...
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Specialist, Regulatory
vor 4 Wochen
München, Deutschland Medpace VollzeitMedpace 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. Our clinical operations...
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Qm Associate
Vor 3 Tagen
München, Deutschland Brainlab Vollzeit**Company Description** Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. Our key to success is our creative, talented and hard-working team, which consists of around 2400 dedicated and inspiring individuals in 25...
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Senior) Regulatory Affairs Expert
vor 16 Stunden
München, Deutschland Ebenbuild Vollzeit**Your mission**: We want you to join our early-stage university spin-off that has just received its ISO 13485 certification. As an integral part of our team, you will harness your regulatory expertise to - develop and implement the regulatory strategy for FDA clearance (De Novo) and conformity assessment under MDR (class II). - create, manage, and maintain...
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München, Deutschland Fortrea Vollzeit 60.000 € - 120.000 € pro JahrJoin Our Team and Drive Clinical Research SuccessAt Fortrea, we are committed to accelerating clinical trials and ensuring regulatory compliance. As a Site Start-Up Specialist, you will play a pivotal role in coordinating site start-up activities, managing essential documents, and ensuring regulatory submissions are completed efficiently. Your expertise will...
