Regulatory Affairs Manager

Wir suchen einen motivierten und erfahrenen Regulatory Affairs Manager, der sich für die Gesundheit von Patient*innen einsetzt und eigenverantwortlich etwas Sinnvolles bewirkt.Als Teil unseres Teams bei Aenova IP GmbH werden Sie an der Entwicklung und Umsetzung von Strategien für die Zulassung von Arzneimitteln und medizinischen Geräten beteiligt. Ihre...

Aufgaben und VerantwortlichkeitenAls Regulatory Affairs Manager bei Aenova IP GmbH sind Sie für die Projektbezogene Zulassungsaufgaben verantwortlich, einschließlich der konzerninternen Koordinierung der Daten- und Dokumentengewinnung. Sie planen, koordinieren und durchführen nationale und internationale Zulassungs-, Verlängerungs- und...

Ihre Aufgaben Als Regulatory Affairs Manager bei Aenova IP GmbH sind Sie für die strategische Planung und Durchführung von Zulassungsprozessen verantwortlich. Sie koordinieren die internationale Zulassung von Medizinprodukten und Arzneimitteln und arbeiten eng mit unseren Entwicklungsteams zusammen. Ihre Kompetenzen Erfolgreich abgeschlossenes...

Wir suchen einen erfahrenen Zulassungsexperten für unsere Location in Marburg, Deutschland.Wenn Sie sich für die Gesundheit von Patient*innen begeistern und eigenverantwortlich wichtige Arbeit leisten möchten, dann sind wir auf der Suche nach Ihnen!Aenova, einer der führenden Auftragshersteller und -entwickler für die Pharmaindustrie, steht für...

Job Title:Regulatory Affairs CMC LeadJob Summary:We are seeking a highly experienced Regulatory Affairs CMC Lead to join our team at Fresenius Kabi. As a key member of our Regulatory Affairs department, you will be responsible for leading and managing CMC regulatory activities related to Biosimilars for development, initial MAA/BLA registration, and...

Job Title: Payroll ManagerThe Payroll Manager position is a critical role within our organization, responsible for overseeing the management of a large payroll team that processes complex payrolls for multiple entities. As the main contact and subject matter expert for the payrolls you support, you will work closely with Payroll Vendors and TLM...

Job DescriptionWe are seeking a highly organized and detail-oriented Global Regulatory Affairs Coordinator to join our team at Fresenius Kabi.Key ResponsibilitiesCoordinate general office administration tasks, including appointment scheduling for the SVP, travel planning, and expense accounting.Organize internal and external meetings, workshops, and other...

For our Clinical Development department, we are seeking a Senior Clinical Development Manager, Immunoglobulins to provide key scientific input to clinical development strategies and therapeutic areas.Key ResponsibilitiesProvides innovative scientific and clinical development leadership for the safe, efficient, and timely execution of assigned programs,...

For our Clinical Development department, we are seeking a clinical scientist to lead key scientific input to clinical development strategies and therapeutic areas, reporting to the Director of Global Clinical Science Lead.The OpportunityProvides scientific and clinical development leadership for the safe, efficient, and timely execution of assigned programs,...

For our Business Excellence and Operations department, we are seeking a Senior Manager, Congress Planning to lead the logistical planning and execution of Above Market congresses.The ideal candidate will have 7+ years of experience in commercial roles in the pharmaceutical/biotech/medical device industry, with 3-5 years of relevant experience in planning and...

As a Senior Analytical Development Manager at FRESENIUS_KABI, you will play a key role in supporting the development of biosimilar products. Your expertise in analytical development will be instrumental in ensuring the quality and compliance of our products.Key responsibilities include:Providing analytical expertise and know-how in the field of mAbs/protein...

For our Business Excellence and Operations department, we are seeking a Senior Manager, Congress Planning to lead the logistical planning and execution for Above Market congresses.Key ResponsibilitiesManage the integrated congress project plan and co-ordinate the congress planning team in partnership with the congress owner.Provide subject matter expertise...

Job SummaryThe Senior Manager, Clinical Trial Supply Chain will lead the end-to-end supply chain for assigned clinical studies, ensuring compliant and on-time delivery of study medication and ancillary materials. This role will independently manage clinical studies, determine kit design and blinding, forecast demand, and establish and manage the depot...

At OSB AG, we are seeking a highly skilled Packaging Specialist to join our team. In this role, you will be responsible for planning and coordinating the labeling, packaging, and release of investigational medicinal products (IMP) for global clinical programs, including Investigator Initiated Trials (IITs).You will ensure regulatory compliance in IMP label...

Are you a detail-oriented professional with a passion for clinical supply chain management?As a Packaging Specialist at OSB AG, you will play a crucial role in ensuring the smooth planning and coordination of labeling, packaging, and release of investigational medicinal products for global clinical programs.Manage material master data, packaging plans, and...

Job Summary:The Senior Manager, Clinical Trial Supply Chain, is a critical role within CSL Behring, responsible for overseeing the end-to-end supply chain for assigned clinical studies. This position requires a strong leader who can independently manage complex clinical studies, ensuring compliant and on-time supply of study medication and ancillary...

Clinical Supply Chain ManagerAt CSL Behring, we are seeking a highly motivated and experienced Clinical Supply Chain Manager to lead our global study management team. This is a unique opportunity to join our dynamic team and contribute to the development and delivery of high-quality medicines that treat people with rare and serious diseases.Job Summary:As a...

The Opportunity:The Clinical Trial Supply Chain Senior Manager is responsible for overseeing the end-to-end supply chain for assigned clinical studies throughout the multi-year study lifecycle. This role independently leads clinical studies to ensure compliant, on-time supply of study medication and ancillary materials for our patients. Key responsibilities...

Job SummaryWe are seeking a Senior Manager, Strategic Forecasting and Analytics to lead our forecasting initiatives centered around decision analytics for the CSL Behring portfolio.Main ResponsibilitiesAs a Senior Manager, Strategic Forecasting and Analytics, you will:Establish processes for decision quality assurance to ensure that decisions are based on...

**Job Summary**Fresenius Kabi is seeking a highly skilled Senior Analytical Life Cycle Manager to join our team. In this role, you will be responsible for providing analytical strategic and scientific expertise to CMC Development Teams in support of submissions to Regulatory authorities for all aspects of CMC analytical packages.**Key...