Aktuelle Jobs im Zusammenhang mit Manager - Global Regulatory Affairs - ATMP (m|f|d) - Bergisch Gladbach - Miltenyi Biomedicine
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Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine VollzeitAbout Miltenyi Biomedicine Miltenyi Biomedicine is a biopharmaceutical company dedicated to developing innovative chimeric antigen receptor (CAR) T-cell therapies for serious life-threatening diseases. Our focus lies in treating difficult-to-manage hematological cancers using CAR-T and other cutting-edge technologies, while also exploring treatments for a...
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Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine VollzeitAbout Miltenyi Biomedicine Miltenyi Biomedicine is a biopharmaceutical company dedicated to developing innovative chimeric antigen receptor (CAR) T-cell therapies for serious life-threatening diseases. Our focus lies in treating difficult-to-manage hematological cancers using CAR-T and other cutting-edge technologies, while also exploring treatments for a...
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Global Regulatory Affairs Manager
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Bergisch Gladbach, Deutschland Miltenyi Biomedicine VollzeitCompany Description Miltenyi Biomedicine is a biopharmaceutical company committed to advancing personalized cell and gene therapies. We are pioneering groundbreaking therapies for serious life-threatening diseases, and reshaping their accessibility for clinical professionals and patients worldwide with the aim to improve and extend patients' lives. We...
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Manager - Global Regulatory Affairs - ATMP (m|f|d)
vor 4 Monaten
Bergisch Gladbach, Deutschland Miltenyi Biomedicine VollzeitCompany Description Miltenyi Biomedicine is a biopharmaceutical company developing personalized chimeric antigen receptor (CAR) T-cell therapies. We are developing innovative treatments for serious life-threatening diseases and are reshaping their accessibility to patients worldwide with the goal of improving and prolonging patients' lives. We are...
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Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine VollzeitJob SummaryWe are seeking a highly skilled Regulatory Affairs Manager to lead our global regulatory strategy for ATMPs and biologics. As a key member of our team, you will be responsible for managing and leading regional teams of regulatory affairs professionals in the EU and EMEA.Key ResponsibilitiesCoordinate strategic regulatory activities with full staff...
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Regulatory Affairs Manager
vor 2 Wochen
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine VollzeitJob SummaryWe are seeking a highly skilled Regulatory Affairs Manager to lead our global regulatory strategy for ATMPs and biologics. As a key member of our team, you will be responsible for managing and leading regional teams of regulatory affairs professionals in the EU and EMEA.Key ResponsibilitiesCoordinate strategic regulatory activities with full staff...
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Global Regulatory Affairs Manager
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Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine VollzeitAbout Miltenyi BiomedicineMiltenyi Biomedicine is a biopharmaceutical company dedicated to advancing personalized cell and gene therapies. Our mission is to improve and extend patients' lives by pioneering groundbreaking therapies for serious life-threatening diseases.Job SummaryWe are seeking a highly skilled Regulatory Affairs representative to manage...
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Global Regulatory Affairs Manager
vor 1 Tag
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine VollzeitAbout Miltenyi BiomedicineMiltenyi Biomedicine is a biopharmaceutical company dedicated to advancing personalized cell and gene therapies. Our mission is to improve and extend patients' lives by pioneering groundbreaking therapies for serious life-threatening diseases.Job SummaryWe are seeking a highly skilled Regulatory Affairs representative to manage...
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Global Regulatory Affairs Manager
vor 10 Stunden
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine VollzeitAbout Miltenyi BiomedicineMiltenyi Biomedicine is a biopharmaceutical company dedicated to advancing personalized cell and gene therapies. Our mission is to improve and extend patients' lives by pioneering groundbreaking therapies for serious life-threatening diseases.Job SummaryWe are seeking a highly skilled Regulatory Affairs representative to manage...
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Global Regulatory Affairs Manager
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Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine VollzeitAbout Miltenyi BiomedicineMiltenyi Biomedicine is a biopharmaceutical company dedicated to advancing personalized cell and gene therapies. Our mission is to pioneer groundbreaking treatments for serious life-threatening diseases, making them more accessible to clinical professionals and patients worldwide.Job SummaryWe are seeking a highly skilled Regulatory...
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Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine VollzeitAbout Miltenyi BiomedicineMiltenyi Biomedicine is a biopharmaceutical company dedicated to advancing personalized cell and gene therapies. Our mission is to pioneer groundbreaking treatments for serious life-threatening diseases, making them more accessible to clinical professionals and patients worldwide.Job SummaryWe are seeking a highly skilled Regulatory...
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Global Regulatory Affairs Manager
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Regulatory Affairs Manager
vor 3 Wochen
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Krüger GmbH & Co. KG VollzeitWir sind eine weltweit agierende Unternehmensgruppe der Lebensmittelindustrie mit rund 5.300 Mitarbeiter*Innen, die in der Zentrale in Bergisch Gladbach sowie in Tochtergesellschaften an verschiedenen Produktionsstandorten im In- und Ausland beschäftigt sind.Unser Unternehmen ist ein führender Anbieter von Instanttee, Cappuccino, Kaffeezubereitungen,...
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Regulatory Affairs Manager
vor 3 Wochen
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Krüger GmbH & Co. KG VollzeitWir sind eine weltweit agierende Unternehmensgruppe der Lebensmittelindustrie mit rund 5.300 Mitarbeiter*Innen, die in der Zentrale in Bergisch Gladbach sowie in Tochtergesellschaften an verschiedenen Produktionsstandorten im In- und Ausland beschäftigt sind.Unser Unternehmen ist ein führender Hersteller von Instanttee, Cappuccino, Kaffeezubereitungen,...
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Regulatory Affairs Manager
Vor 7 Tagen
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Krüger GmbH & Co. KG VollzeitÜberblickWir suchen einen erfahrenen Regulatory Affairs-Experten, der unsere Nahrungsergänzungsmittel auf internationalen Märkten registrieren und zulassen möchte. Als Regulatory Affairs Manager werden Sie Teil unseres Teams und sind für die Überwachung der globalen regulatorischen Anforderungen verantwortlich.Ihre AufgabenErstellen Sie die...
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Regulatory Affairs Manager
Vor 7 Tagen
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Krüger GmbH & Co. KG VollzeitÜberblickWir suchen einen erfahrenen Regulatory Affairs-Experten, der unsere Nahrungsergänzungsmittel auf internationalen Märkten registrieren und zulassen möchte. Als Regulatory Affairs Manager werden Sie Teil unseres Teams und sind für die Überwachung der globalen regulatorischen Anforderungen verantwortlich.Ihre AufgabenErstellen Sie die...
Manager - Global Regulatory Affairs - ATMP (m|f|d)
vor 4 Monaten
- You will be responsible for managing and leading regional teams of regulatory affairs professionals in the EU and EMEA for new and approved products on a national or international basis.
- This includes coordinating strategic regulatory activities with full staff and product management authority, as well as regional regulatory strategy and planning in line with the global regulatory strategy.
- Working closely with health authorities to coordinate, communicate and manage all regulatory interactions is another essential part of this position.
- You will also oversee relevant aspects of product safety and quality regarding pharmacovigilance and regulatory requirements.
- Leading the development and maintenance of prescribing information and risk management plans completes the diverse range of responsibilities.
Qualifications
- M.D., Ph.D., or Master's degree in pharmacy, biology, chemistry, or a related field. An advanced degree or certificate in regulatory science is preferred, but not required.
- Several years of relevant experience in EU regulatory affairs, drug development and/or submission management with a focus on ATMPs and biologics.
- Sound business judgment and collaborative skills, as well as proven ability to interact and influence at all levels of a dynamic organization.
- Ability to build and maintain strong cross-functional relationships, to challenge traditional views while respecting best practices, and to present and argue cases in a professional and respectful manner.
- You have a proven track record of successfully leading and developing a team.
- You are a self-starter with excellent organizational and communication skills in English, basic skills in German are preferred, but not required. Willingness to travel internationally (10%)
Additional Information
What we offer
- A modern workplace in Bergisch Gladbach with opportunity for some mobile work. Exciting opportunities in the development of technologies with a secure future.
- Cross-border intercultural cooperation and short communication channels
- A collegial corporate culture and flexible working hours enable time management on your own terms
- Personalized employee development program: specialist and personal training courses provided by our own Miltenyi University
- Diverse corporate benefits with regard to employee health, sport, and staff events
We look forward to your application
If you would like to work in an open, creative and helpful team, we offer you the right environment here. We look forward to receiving your application - with your salary expectations and availability.
