Experienced Regulatory Submissions
vor 1 Woche
Medpace OverviewMedpace 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 SummaryAs 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.ResponsibilitiesPrepare, 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.QualificationsA 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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Experienced Regulatory Submissions
vor 3 Wochen
Munich, Deutschland Medpace VollzeitMedpace OverviewMedpace 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...
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Regulatory Submission Associate
vor 1 Woche
Munich, Deutschland Fortrea - Organic VollzeitAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
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Regulatory Affairs Specialist
vor 3 Wochen
Munich, Deutschland EPM Scientific VollzeitRegulatory Affairs Specialist - Medical Device Manufacturing Project (Bavaria 🇩🇪)We're hiring Regulatory Affairs Specialists for a major medical device manufacturing project based in Bavaria! Join a leading Medical Device Company in a hybrid role supporting regulatory submissions, compliance activities, and alignment with EU and international medical...
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Regulatory Affairs Manager
Vor 4 Tagen
Munich, Deutschland Cpl Life Sciences Vollzeitob Title: European Regulatory Affairs ManagerLocation: Munich, Germany - Hybrid, 3x a week in the officeRemuneration: Competitive salary and packageRegulatory 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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Associate Director Regulatory Affairs
vor 1 Woche
Munich, Bayern, Deutschland Medella Life Vollzeit 90.000 € - 120.000 € pro JahrJob Purpose / SummaryThe Associate Director (RA) will lead regulatory strategy, submissions, and lifecycle maintenance for assigned products / projects in the European / German / Central Eastern Europe region. This role ensures compliance with regulatory requirements, supports product development from early phase through to post-marketing, and acts as the...
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Munich, Deutschland Infosys Consulting - Europe VollzeitAll candidates should have a passion for helping our clients navigate transformational change; We are looking for smart, self-driven, high-energy people with top-notch communication skills, intellectual curiosity. The Candidate should have a rare blend of industry domain, process, technical and consulting skills. Industry domain expertise can be in one or...
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Munich, Bayern, Deutschland Infosys Consulting - Europe Vollzeit 80.000 € - 120.000 € pro JahrAll candidates should have a passion for helping our clients navigate transformational change; We are looking for smart, self-driven, high-energy people with top-notch communication skills, intellectual curiosity. The Candidate should have a rare blend of industry domain, process, technical and consulting skills. Industry domain expertise can be in one or...
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Regulatory Operations Specialist
vor 2 Wochen
Munich, Deutschland Daiichi-Sankyo Europe Vollzeit**Passion for Innovation. Compassion for Patients.**: **Regulatory Operations Specialist (M/F/x)**: **The position**: Under supervision, provide regulatory operational support for European submission projects for prospective and authorize products in a timely manner. Ensure regulatory operations compliance and may act as a specialist in a particular area. In...
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Regulatory Officer
vor 3 Wochen
Munich, 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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Munich, Deutschland Organon VollzeitJob DescriptionThe PositionCoordinating and supporting all regulatory activities to maintain registrations and to obtain new marketing authorisations for the company portfolio/pipeline subject to EU procedures (Centralised, Mutual Recognition, Decentralised, National authorised Procedures) across therapeutic areas. The position also requires strong project...
