Regulatory Affairs Specialist

vor 1 Woche

Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

Company Overview

Miltenyi Biomedicine is a biopharmaceutical company dedicated to advancing personalized cell and gene therapies. We are pioneering groundbreaking treatments for serious life-threatening diseases, aiming to improve and extend patients' lives.

Job Responsibilities

  • Manage investigational and approved advanced medicinal therapy products on a national or international basis, including operational responsibility for one or more products and regional regulatory strategy planning.
  • Coordinate and communicate with health authorities to manage regulatory interactions, contributing to product safety and quality regarding pharmacovigilance and regulatory requirements.
  • Develop and maintain prescribing information and risk management plans.

Requirements

  • M.D., Ph.D., or other degree in pharmacy, biology, chemistry, or a related field, with an advanced degree or certificate in regulatory science preferred.
  • 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, collaborative skills, and ability to interact and influence at all levels of a dynamic organization.
  • Excellent organizational and communication skills in English, with basic skills in German preferred.

What We Offer

  • A modern workplace in Bergisch Gladbach with opportunities for mobile work and exciting career development.
  • Cross-border intercultural cooperation and short communication channels.
  • A collegial corporate culture and flexible working hours.
  • Personalized employee development program and diverse corporate benefits.

  • Regulatory Affairs Specialist

    vor 2 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

    Company OverviewMiltenyi 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 SummaryAs a Regulatory Affairs representative, you will be responsible for managing...

  • Global Regulatory Affairs Specialist

    vor 2 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

    Company OverviewMiltenyi Biomedicine is a biopharmaceutical company dedicated to advancing personalized cell and gene therapies. Our mission is to improve and extend patients' lives by developing groundbreaking treatments for serious life-threatening diseases.Job SummaryAs a Regulatory Affairs representative, you will be responsible for managing...

  • Regulatory Affairs Manager

    vor 2 Monaten

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

    Job 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...

  • Regulatory Affairs Manager

    vor 2 Monaten

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

    Job 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...

  • Regulatory Affairs Leader

    Vor 7 Tagen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

    Company OverviewMiltenyi Biomedicine is a leading biopharmaceutical company focused on developing innovative treatments for serious life-threatening diseases. Our mission is to improve and prolong patients' lives through the development of personalized chimeric antigen receptor (CAR) T-cell therapies.Job SummaryWe are seeking a highly experienced Regulatory...

  • Global Regulatory Affairs Manager

    vor 1 Monat

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

    Company OverviewMiltenyi 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...

  • Global Regulatory Affairs Manager

    vor 1 Monat

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

    Company OverviewMiltenyi 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...

  • Global Regulatory Affairs Manager

    vor 4 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

    Company OverviewMiltenyi Biomedicine is a biopharmaceutical company dedicated to advancing personalized cell and gene therapies. Our mission is to improve and extend patients' lives by developing groundbreaking treatments for serious life-threatening diseases.Job SummaryWe are seeking a highly skilled Regulatory Affairs representative to manage...

  • Global Regulatory Affairs Manager

    vor 4 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

    Company OverviewMiltenyi Biomedicine is a biopharmaceutical company dedicated to advancing personalized cell and gene therapies. Our mission is to improve and extend patients' lives by developing groundbreaking treatments for serious life-threatening diseases.Job SummaryWe are seeking a highly skilled Regulatory Affairs representative to manage...

  • Global Regulatory Affairs Manager

    vor 1 Monat

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

    Company OverviewMiltenyi Biomedicine is a biopharmaceutical company dedicated to advancing personalized cell and gene therapies. Our mission is to improve and extend patients' lives by developing groundbreaking treatments for serious life-threatening diseases.Job SummaryWe are seeking a highly skilled Regulatory Affairs representative to manage...

  • Global Regulatory Affairs Manager

    vor 1 Monat

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

    Company OverviewMiltenyi Biomedicine is a biopharmaceutical company dedicated to advancing personalized cell and gene therapies. Our mission is to improve and extend patients' lives by developing groundbreaking treatments for serious life-threatening diseases.Job SummaryWe are seeking a highly skilled Regulatory Affairs representative to manage...

  • Global Regulatory Affairs Manager

    vor 2 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

    About 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 developing groundbreaking treatments for serious life-threatening diseases.Job SummaryWe are seeking a highly skilled Regulatory Affairs professional to join our...

  • Regulatory Affairs Manager

    vor 4 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Krüger GmbH & Co. KG Vollzeit

    Unser AngebotWir suchen einen erfahrenen Regulatory Affairs-Experten, der unsere Nahrungsergänzungsmittel auf internationalen Märkten registrieren und zulassen kann. Als Regulatory Affairs Manager werden Sie Teil unseres Teams und sind verantwortlich für die Überwachung der globalen regulatorischen Anforderungen.Ihre AufgabenErstellen Sie die...

  • Regulatory Affairs Manager

    vor 4 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Krüger GmbH & Co. KG Vollzeit

    Unser AngebotWir suchen einen erfahrenen Regulatory Affairs-Experten, der unsere Nahrungsergänzungsmittel auf internationalen Märkten registrieren und zulassen kann. Als Regulatory Affairs Manager werden Sie Teil unseres Teams und sind verantwortlich für die Überwachung der globalen regulatorischen Anforderungen.Ihre AufgabenErstellen Sie die...

  • Regulatory Affairs Manager

    vor 3 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Krüger GmbH & Co. KG Vollzeit

    Unser AngebotWir suchen einen erfahrenen Regulatory Affairs-Experten, der unsere Nahrungsergänzungsmittel auf internationalen Märkten registrieren und zulassen kann. Als Regulatory Affairs Manager werden Sie Teil unseres Teams und sind verantwortlich für die Überwachung der globalen regulatorischen Anforderungen.Ihre AufgabenErstellen Sie die...

  • Regulatory Affairs Manager

    vor 3 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Krüger GmbH & Co. KG Vollzeit

    Unser AngebotWir suchen einen erfahrenen Regulatory Affairs-Experten, der unsere Nahrungsergänzungsmittel auf internationalen Märkten registrieren und zulassen kann. Als Regulatory Affairs Manager werden Sie Teil unseres Teams und sind verantwortlich für die Überwachung der globalen regulatorischen Anforderungen.Ihre AufgabenErstellen Sie die...

  • Regulatory Affairs Manager

    vor 2 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

    Job Title: Regulatory Affairs Manager - ATMPCompany Overview:Miltenyi Biomedicine is a biopharmaceutical company dedicated to developing personalized chimeric antigen receptor (CAR) T-cell therapies. Our mission is to improve and prolong patients' lives by creating innovative treatments for serious life-threatening diseases.Job Summary:Manage and lead...

  • Regulatory Affairs Manager

    vor 1 Woche

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

    Company OverviewMiltenyi Biomedicine is a biopharmaceutical company dedicated to developing personalized chimeric antigen receptor (CAR) T-cell therapies. Our mission is to improve and prolong patients' lives by creating innovative treatments for serious life-threatening diseases.Job SummaryManage and lead regional teams of regulatory affairs professionals...

  • Regulatory Affairs Manager

    vor 1 Monat

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

    Company OverviewMiltenyi Biomedicine is a biopharmaceutical company dedicated to developing personalized chimeric antigen receptor (CAR) T-cell therapies for serious life-threatening diseases. Our mission is to improve and prolong patients' lives by bringing innovative treatments to market.Job SummaryWe are seeking a highly skilled Regulatory Affairs Manager...

  • Regulatory Affairs Manager

    vor 1 Monat

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

    Company OverviewMiltenyi Biomedicine is a biopharmaceutical company dedicated to developing personalized chimeric antigen receptor (CAR) T-cell therapies for serious life-threatening diseases. Our mission is to improve and prolong patients' lives by bringing innovative treatments to market.Job SummaryWe are seeking a highly skilled Regulatory Affairs Manager...