Regulatory Affairs Manager

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...

Über uns Aenova ist eine der weltweit führenden Auftragshersteller und -entwickler für die Pharmaindustrie. Wir suchen einen erfahrenen Regulatory Affairs Manager, der unsere Zulassungs- und Compliance-Prozesse unterstützt. Ihre Aufgaben Zuständigkeit für ein definiertes Produktsortiment mit Verantwortung für die projektbezogen anfallenden...

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 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...

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...

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...

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...

The OpportunityWe are seeking a highly skilled Governance Contracting and Process Excellence Lead to join our team in the Enterprise Contracting Center. As a key member of our team, you will play a critical role in ensuring our contracts comply with legal requirements, are enterprise-wide harmonized, and optimized for efficiency. This is a Senior...

As an Analytical Life Cycle Manager at FRESENIUS_KABI, you will play a crucial role in supporting the development of biosimilar products. Your primary focus will be on providing analytical strategic and scientific expertise to CMC Development Teams, ensuring compliance with regulatory requirements.Key Responsibilities:Supply analytical strategic and...

Job Overview:Fresenius Kabi is seeking a highly skilled Scientific Lead for our Biosimilar Development team. This role will be responsible for leading the development of analytical packages for biosimilar products, ensuring compliance with global health authorities' requirements.About You:We are looking for an individual with a strong background in...

Fresenius Digital Technology is seeking a highly experienced professional to lead the implementation of SAP S/4HANA and ensure compliance with regulatory requirements. As an internal IT service provider, we support all business units of the Fresenius Group with innovative and reliable IT services.**Key Responsibilities:**Manage the setup of a qualified and...

We are seeking a highly skilled Strategic Procurement Manager to drive our API & Ingredients sourcing strategy forward.As a Strategic Procurement Manager, you will oversee supplier relationships for APIs and ingredients critical to our parenteral and enteral nutrition products. Your responsibilities will include supplier selection and contract negotiations,...

We are seeking a highly skilled Strategic Procurement Manager to drive our API & Ingredients sourcing strategy forward.As a Strategic Procurement Manager, you will oversee the full supplier lifecycle for APIs and Ingredients, including selection, qualification, and ongoing performance management.Your Key ResponsibilitiesStrategic Supplier Management: Oversee...