Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Manager - Dreieich - Biotest AG
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Dreieich, Deutschland Hitachi Vantara VollzeitThe Role We are looking for an experienced HR, Legal Affairs and Works Council Partner to manage the interface between the Hitachi Vantara business, the Human Resources department and the Works Council in Germany. In this role you will nurture a constructive relationship between Employer and the Works council, serving both the employee and company...
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Quality Assurance Specialist
vor 4 Wochen
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Quality Assurance Specialist
vor 4 Wochen
Dreieich, Hessen, Deutschland Danaher USA VollzeitJoin Our Team as a Quality Assurance EngineerTransforming Human Health, One Solution at a TimeAt Danaher, we're committed to advancing future therapeutics from discovery to delivery. As a Quality Assurance Engineer, you'll play a critical role in ensuring our products meet the highest standards of quality and regulatory compliance.Key...
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Quality Assurance Specialist
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Dreieich, Hessen, Deutschland Danaher USA VollzeitTransforming Human HealthCytiva is at the forefront of providing innovative solutions to advance life-changing therapeutics. As a Quality Assurance Engineer, you will play a crucial role in ensuring our products meet the highest standards of quality, safety, and efficacy.Our team is dedicated to developing next-generation life-saving treatments, and we need...
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Quality Assurance Specialist
vor 4 Wochen
Dreieich, Hessen, Deutschland Cytiva VollzeitQuality Assurance EngineerCytiva is a leading provider of innovative solutions for the life sciences industry. We are seeking a highly skilled Quality Assurance Engineer to join our team in Dreieich, Germany.Key Responsibilities:Manage and improve the Quality Management System to ensure compliance with Cytiva, customer, and regulatory requirements.Develop...
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Quality Assurance Specialist
vor 4 Wochen
Dreieich, Hessen, Deutschland Cytiva VollzeitQuality Assurance EngineerCytiva is a leading provider of innovative solutions for the life sciences industry. We are seeking a highly skilled Quality Assurance Engineer to join our team in Dreieich, Germany.Key Responsibilities:Manage and improve the Quality Management System to ensure compliance with Cytiva, customer, and regulatory requirements.Develop...
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Quality Assurance Specialist
vor 2 Wochen
Dreieich, Hessen, Deutschland Cytiva VollzeitAbout the RoleWe are seeking a highly skilled Quality Assurance Engineer to join our team at Cytiva. As a Quality Assurance Engineer, you will play a critical role in maintaining and improving our Quality Management System, ensuring that we meet customer, regulatory, and Cytiva requirements through project execution and delivery of products.Key...
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Senior Employee Relations and Works Council Partner
vor 3 Wochen
Dreieich, Hessen, Deutschland Hitachi Vantara VollzeitThe RoleWe are seeking an experienced HR and Legal Affairs professional to manage the interface between Hitachi Vantara's business, the Human Resources department, and the Works Council in Germany. In this role, you will foster a constructive relationship between the Employer and the Works Council, serving both employee and company interests. You will ensure...
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Senior Implementation Specialist
vor 2 Monaten
Dreieich, Deutschland Thermo Fisher Scientific VollzeitWhen you’re part of Thermo Fisher Scientific, you’ll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the...
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Technical Lead Qualifications Services
vor 2 Monaten
Dreieich, Deutschland Cytiva Vollzeit**Be part of something altogether life-changing!** Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be...
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Technical Lead Qualifications Services
vor 2 Monaten
Dreieich, Deutschland Danaher Corporation VollzeitBe part of something altogether life-changing! Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be...
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Quality Assurance Engineer
vor 1 Monat
Dreieich, Deutschland Cytiva VollzeitBe part of something altogether life-changing!Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to...
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Quality Assurance Engineer
vor 2 Wochen
Dreieich, Deutschland Cytiva VollzeitBe part of something altogether life-changing!Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to...
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Technical Lead Qualifications Services
vor 1 Monat
Dreieich, Deutschland Cytiva VollzeitBe part of something altogether life-changing!Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to...
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Quality Assurance Engineer
vor 2 Monaten
Dreieich, Deutschland Cytiva VollzeitBe part of something altogether life-changing!Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to...
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Quality Assurance Engineer
vor 1 Monat
Dreieich, Deutschland Cytiva VollzeitBe part of something altogether life-changing!Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to...
Regulatory Affairs Manager
vor 2 Monaten
So international wie ein Konzern, so persönlich wie ein Mittelständler, das ist die Kultur bei Biotest. Als weltweiter Spezialist für Immunologie und Hämatologie heißt unsere Mission „Leben retten“. Mit innovativen Produkten und richtungsweisender Forschung geben wir chronisch Kranken neue Perspektiven. Motivierte Mitarbeitende sind da ein Muss. Individuelle Förderung und Entwicklungsperspektiven gehören darum zu unserem Alltag. Werden Sie Teil einer 2.300 Mitarbeitenden starken Idee.
- Regulatorische Betreuung der Biotest Entwicklungsprodukte
- Entwicklung und Umsetzung regulatorischer Strategien für vermarktete und Biotest Entwicklungsprodukte u.a. für den US Markt
- Regulatorische Mitarbeit in interdisziplinären Projektteams, bei der Planung von regulatorischen Strategien und der Vorbereitung von wissenschaftlichen Beratungsgesprächen bei Behörden
- Erstellung und Aktualisierung von Zulassungsdokumenten in Zusammenarbeit mit internen Fachabteilungen und externen Partnern
- Erstellung von Anträgen zur Genehmigung von Klinischen Prüfungen, Neuzulassungen (BLA) und Maintenance bestehender Zulassungen
- Schnittstelle zu weltweiten Zulassungsbehörden (z.B. FDA)
- Abgeschlossenes Studium der Naturwissenschaft (Medizin, Biologie, Pharmazie) oder vergleichbare Ausbildung
- Aufbaustudiengang im Bereich Regulatory Affairs (z.B. DGRA, EUCRAF) von Vorteil
- Erfahrungen im Bereich Regulatory Affairs von Vorteil
- Sehr gute Englischkenntnisse
- Sehr gute MS Office-Kenntnisse
- Fähigkeit zu vernetztem, interdisziplinären und strategischem Denken
- Sehr gute organisatorische und analytische Fähigkeiten verbunden mit hohem Qualitätsbewusstsein
- Flache Hierarchien sowie angenehmes Arbeitsumfeld
- Individuelles Einarbeitungsprogramm
- Attraktive Vergütung
- Corporate Benefits (Rabatte für unsere Mitarbeitenden)
- Kantine und Verpflegungszuschuss
- Kindertagesstätte „BioNest“
- Fortbildungen und Trainings
- Kostenfreies Parkhaus für unsere Mitarbeitenden inkl. Lademöglichkeiten für Ihr E-Auto
