Regulatory Affairs Lead Biosimilars

FORTNA, a leading provider of innovative solutions for omnichannel and parcel distribution operations, is seeking an experienced Senior Mechanical Engineer to join our team. As a key member of our project delivery team, you will be responsible for delivering high-quality projects on time and within budget.About the Role:Develop and maintain in-depth...

Job SummaryWe are seeking a highly skilled and experienced Senior Manager, Logistics Execution System to join our Industrial Solutions team. In this role, you will be responsible for overseeing the efficient and effective operation of our logistics execution system, with a focus on supporting the business through technology solutions.Key ResponsibilitiesLead...

**Your tasks**: - For the assigned products/programs, define and execute an RA-CMC Strategy that best serves the biosimilars business needs and ensure compliance with regulatory requirements - Plan, prepare and coordinate CMC related submissions with CMC and regulatory functions - Track approval and provide regulatory input for changes implementation...

**Your tasks**: - Strategische und operative Leitung der Abteilung Regulatory Affairs, Pharmakovigilance und Quality Management in der Market Unit Austria - Personal - und Budgetverantwortung der Abteilung - Verantwortung aller Systeme und Prozesse in den Bereichen Reg. Affairs, Informationsbeauftragung, Pharmakovigilanz, Qualitätsmanagement und Compliance...

At MEON, we develop, manufacture and market high-quality, modern and innovative medical devices in the field of in vitro diagnostics for professional use in clinics, medical laboratories and doctors’ offices. Our interdisciplinary teams are highly motivated and built on a broad range of technical expertise with a strong technical foundation in domains such...

**m / w / d - Vollzeit/Teilzeit - Graz**: **Das Institut AllergoSan verfügt über 30 Jahre Erfahrung in der Erforschung und Entwicklung von Probiotika, pflanzlichen Wirkstoffen und orthomolekularer Medizin. Qualität liegt in unserer DNA - dank intensiver wissenschaftlicher Forschung und spürbarer Wirksamkeit ist unsere Marke OMNi-BiOTiC® seit Jahren die...

**Ihre Aufgaben und Verantwortlichkeiten**: Die Abteilung Regulatory Affairs ist in einem gruppenweit agierenden R&D Kompetenzzentrum der Constantia Flexibles eingegliedert. In dieser Position sind Sie zuständig für die Sicherstellung der Konformität und Sicherheit der Produkte, die am Standort in Weinburg produziert werden und begleiten auch...

**m / w / d - Teilzeit - Graz**: **Werden Sie Teil unserer Erfolgsgeschichte!** Denn Das Institut AllergoSan verfügt über 30 Jahre Erfahrung in der Erforschung und Entwicklung von Probiotika, pflanzlichen Wirkstoffen und orthomolekularer Medizin. Qualität liegt in unserer DNA - dank intensiver wissenschaftlicher Forschung und spürbarer Wirksamkeit ist...

**Your tasks**: - Oversee and guide drug product activities including drug product process development, technology transfer, process characterization and validation and submission of CMC documents to Regulatory Authorities - Define technical development that follows the principles of Quality by Design (QbD) and specify activities, milestones and costs -...

Sie arbeiten gerne an präzisen Messinstrumenten und haben Freude an der Erarbeitung von Strategien um globale Märkte zu erreichen? Wir arbeiten kontinuierlich daran, herausragende und Innovative Messlösungen für unsere Kundinnen und Kunden auf der ganzen Welt zu Verfügung zu stellen. Als Teil unserer Abteilung Produktsicherheit in der Anton Paar Gruppe...

**Your tasks**: - Provide analytical expertise and know how in the field of mAbs/protein analytics to deliver industry leading analytical packages in support of Fresenius Kabi Biosimilar Product development of the required standard for adherence to Global Health Authorities (in particular US and EU) requirements - Collaborate with CMC Development teams,...

(Deutsche Version weiter unten) The MEON group designs, develops and markets high-quality, modern and innovative medical devices for in-vitro diagnostics used in clinics, medical laboratories and doctors’ offices. Our interdisciplinary teams are highly motivated and built on a broad range of technical expertise with a strong technical foundation in domains...

At MEON, we develop, manufacture and market high-quality, modern and innovative medical devices in the field of in vitro diagnostics for professional use in clinics, medical laboratories and doctors’ offices. Our interdisciplinary teams are highly motivated and built on a broad range of technical expertise with a strong technical foundation in domains such...

Company Description Company Name: FIS Global **Job Description**: **Job Title**: Business Process Manager (M/F/d) **Job Type**: Full-time **Experience Level**: Experienced (relevant combination of work and education) **Education Requirement**: Bachelor of Business Administration **Travel Percentage**: 15 - 25% - The world of finance moves fast. At FIS, we...

**Full-time position, starting immediately in Graz, Austria.** We believe in building a future where preclinical experiments are highly automated, scalable, close to the clinical reality of diseases, and the cost of failing is low. We believe in making drug development flywheels and precision medicine a reality. Our team strives to offer more reliable,...

The Research Center Pharmaceutical Engineering GmbH (RCPE) is a global leader in pharmaceutical engineering sciences. We help our partners create and manufacture advanced medicines for patients worldwide through optimizing products and processes. For our team / area Next-generation manufacuturing we are looking for an active, highly qualified...

**Group Description** At Magna, we create technology that disrupts the industry and solves big problems for consumers, our customers, and the world around us. We’re the only mobility technology company and supplier with complete expertise across the entire vehicle. We are committed to quality and continuous improvement because our products impact...

Österreich : Graz - ‎- Anton Paar develops, produces and distributes highly accurate laboratory instruments and process measuring systems, and provides custom-tailored automation and robotic solutions. It is the world leader in the measurement of density, concentration and CO2 and in the field of rheometry. As the Market Development Manager, you are...

We are seeking an experienced Electrical Project Manager to join our international company at one of our production sites in Poland. As an Electrical Project Manager, you will be responsible for overseeing and managing electrical projects related to our investment initiatives. Your expertise will be instrumental in ensuring the successful execution...

**Job Number**: 58972 **Group**: Magna Corporate **Division**: Magna International Graz **Job Type**: Permanent/Regular **Location**: GRAZ **Group Description** At Magna, we create technology that disrupts the industry and solves big problems for consumers, our customers, and the world around us. We’re the only mobility technology company and supplier...

I am working with a dynamic and fast-growing consultancy that specialises in functional safety and quality across various high-tech industries, including robotics, medical devices, automotive, and semiconductors. They are looking for a Functional Safety Engineer to join their team, who thrives on variety and is eager to work across multiple industries. This...

**What you will enjoy doing**: In this role, you will oversee all maintenance activities within the region, leading a team of maintenance professionals and implementing strategies to minimize downtime and optimize equipment performance. You will work closely with the production and engineering teams to maintain high-quality standards and support the...