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9 Treffer für Regulatory Affairs Manager Jobs in Koblenz im Umkreis von 30 km
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. * Du arbeitest eng mit Produktentwicklung, IT, Regulatory Affairs und Management zusammen, um ein modernes, skalierbares Qualitätsverständnis entlang des gesamten Produktlebenszyklus zu verankern.
. * Du arbeitest eng mit Produktentwicklung, IT, Regulatory Affairs und Management zusammen, um ein modernes, skalierbares Qualitätsverständnis entlang des gesamten Produktlebenszyklus zu verankern.
AsHead of Software Product Management (m/f/d)for one of our business areas, youcoordinate, manage, and inspirea high-performing team ofproduct managers, product owners, and requirements engineers. * Comprehensive expertise in data management, data protection, and regulatory requirements, enabling you to craftinnovative solutionsthat comply withthe highest standards.
AsHead of Software Product Management (m/f/d)for one of our business areas, youcoordinate, manage, and inspirea high-performing team ofproduct managers, product owners, and requirements engineers. * Comprehensive expertise in data management, data protection, and regulatory requirements, enabling you to craftinnovative solutionsthat comply withthe highest standards.
Schnelle Bewerbung
At the same time, you effectively engage with global regulatory authorities, scientific organizations, and industry networks to ensure visibility, strengthen collaboration, and maintain strategic influence. Define and drive the global Knowledge Hub strategy, including long-term priorities, governance models, and strategic roadmaps to strengthen knowledge management and regulatory intelligence capabilities. Regulatory Intelligence & Knowledge Dissemination - Ensure systematic screening, evaluation, and dissemination of regulatory guidelines and scientific intelligence relevant to RA, QA, and PV, enabling informed and timely decision-making. Engage with global regulatory authorities, scientific organizations, and industry networks, representing the company in external forums, working groups, and conferences to maintain visibility and influence. Regulatory Intelligence & Knowledge Management Expertise
At the same time, you effectively engage with global regulatory authorities, scientific organizations, and industry networks to ensure visibility, strengthen collaboration, and maintain strategic influence. Define and drive the global Knowledge Hub strategy, including long-term priorities, governance models, and strategic roadmaps to strengthen knowledge management and regulatory intelligence capabilities. Regulatory Intelligence & Knowledge Dissemination - Ensure systematic screening, evaluation, and dissemination of regulatory guidelines and scientific intelligence relevant to RA, QA, and PV, enabling informed and timely decision-making. Engage with global regulatory authorities, scientific organizations, and industry networks, representing the company in external forums, working groups, and conferences to maintain visibility and influence. Regulatory Intelligence & Knowledge Management Expertise
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Ensure compliance with legal, regulatory, ISO, and Group EHS standards across all hub sites.
Ensure compliance with legal, regulatory, ISO, and Group EHS standards across all hub sites.
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Global Head of Science Affiliates (m/f/d)
Global Head of Science Affiliates (m/f/d)
CHEPLAPHARM Arzneimittel GmbH
Berlin, Binningen, Greifswald
Schnelle Bewerbung
Build and maintain strategic relationships with scientific institutions, regulatory authorities, and international partners to strengthen the global affiliate network and scientific collaboration. Ensure compliance with international standards and regulatory requirements while supporting the adaptation of global quality management systems to local needs.
Build and maintain strategic relationships with scientific institutions, regulatory authorities, and international partners to strengthen the global affiliate network and scientific collaboration. Ensure compliance with international standards and regulatory requirements while supporting the adaptation of global quality management systems to local needs.
Global Head of Product Operations (m/f/d)
Global Head of Product Operations (m/f/d)
CHEPLAPHARM Arzneimittel GmbH
Berlin, Binningen, Greifswald
Teilweise Home-Office
Schnelle Bewerbung
Oversee and manage market complaints, claims, and recall activities to ensure timely resolution, minimize business impact, and maintain full regulatory compliance. Build and maintain strong relationships with internal functions, affiliates, regulatory stakeholders, and external partners to support sustainable quality operations. Quality & Regulatory Expertise - Deep expertise in pharmaceutical quality management within GMP/GDP-regulated environments, including complaints, recalls, and regulatory compliance processes.
Oversee and manage market complaints, claims, and recall activities to ensure timely resolution, minimize business impact, and maintain full regulatory compliance. Build and maintain strong relationships with internal functions, affiliates, regulatory stakeholders, and external partners to support sustainable quality operations. Quality & Regulatory Expertise - Deep expertise in pharmaceutical quality management within GMP/GDP-regulated environments, including complaints, recalls, and regulatory compliance processes.
Global Head of Quality (m/f/d)
Global Head of Quality (m/f/d)
CHEPLAPHARM Arzneimittel GmbH
Berlin, Binningen, Greifswald
Teilweise Home-Office
Schnelle Bewerbung
Lead Product Integration Managers and oversee major integration and due diligence projects, ensuring high-quality execution and alignment with global standards. Ensure compliance with GMP/GDP and global regulatory requirements while driving the effective use of enterprise quality systems, processes, and IT solutions. Regulatory & Quality Expertise - Deep expertise in GMP/GDP regulations and global regulatory requirements with strong understanding of quality systems in a pharmaceutical context. Proven ability to build and maintain relationships with regulatory authorities and external in a global environment.
Lead Product Integration Managers and oversee major integration and due diligence projects, ensuring high-quality execution and alignment with global standards. Ensure compliance with GMP/GDP and global regulatory requirements while driving the effective use of enterprise quality systems, processes, and IT solutions. Regulatory & Quality Expertise - Deep expertise in GMP/GDP regulations and global regulatory requirements with strong understanding of quality systems in a pharmaceutical context. Proven ability to build and maintain relationships with regulatory authorities and external in a global environment.
Global Head of Quality Systems (m/f/d)
Global Head of Quality Systems (m/f/d)
CHEPLAPHARM Arzneimittel GmbH
Berlin, Binningen, Greifswald
Teilweise Home-Office
Schnelle Bewerbung
Accountable for data integrity governance across all systems and documentation, including oversight of computerized system validation (CSV) and compliance with global regulatory requirements. Lead quality governance initiatives and QMS improvement programs, ensuring continuous enhancement of system effectiveness in alignment with regulatory expectations and company quality objectives. Foster cross-functional alignment across departments and serve as primary interface for escalation topics, while engaging with regulatory authorities, CMOs, suppliers, and other external on quality system requirements. Quality Systems & Regulatory Expertise - Deep expertise in QMS design, eQMS platforms, data integrity governance, and global regulatory compliance across multiple GxP domains. Experience in collaborating with regulatory authorities and managing external partners such as CMOs and ...
Accountable for data integrity governance across all systems and documentation, including oversight of computerized system validation (CSV) and compliance with global regulatory requirements. Lead quality governance initiatives and QMS improvement programs, ensuring continuous enhancement of system effectiveness in alignment with regulatory expectations and company quality objectives. Foster cross-functional alignment across departments and serve as primary interface for escalation topics, while engaging with regulatory authorities, CMOs, suppliers, and other external on quality system requirements. Quality Systems & Regulatory Expertise - Deep expertise in QMS design, eQMS platforms, data integrity governance, and global regulatory compliance across multiple GxP domains. Experience in collaborating with regulatory authorities and managing external partners such as CMOs and ...
Global Head of Science Experts (m/f/d)
Global Head of Science Experts (m/f/d)
CHEPLAPHARM Arzneimittel GmbH
Berlin, Binningen, Greifswald
Teilweise Home-Office
Schnelle Bewerbung
You define the global scientific strategy for specialized pharmaceutical areas and establish long-term priorities and roadmaps that strengthen product robustness and regulatory compliance. Lead and manage outsourcing activities and act as primary interface to regulatory authorities, scientific institutions, and industry networks. Evaluate scientific risks in areas with uncertain data, assess medium-term impact, and ensure informed decision-making in line with strategic and regulatory requirements. Extensive national and international scientific network with experience representing organizations in external scientific forums and regulatory interactions.
You define the global scientific strategy for specialized pharmaceutical areas and establish long-term priorities and roadmaps that strengthen product robustness and regulatory compliance. Lead and manage outsourcing activities and act as primary interface to regulatory authorities, scientific institutions, and industry networks. Evaluate scientific risks in areas with uncertain data, assess medium-term impact, and ensure informed decision-making in line with strategic and regulatory requirements. Extensive national and international scientific network with experience representing organizations in external scientific forums and regulatory interactions.
16 passende Jobs liegen außerhalb deiner Region
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Schnelle Bewerbung
Als Regulatory Affairs Manager übernehmen Sie Verantwortung für den regulatorischen Bereich und bringen Ihre Erfahrung dort ein, wo sie wirklich gebraucht wird. Sie möchten nicht nur technische Dokumentationen pflegen, sondern Regulatory Affairs aktiv mitgestalten? * Mehrjährige Berufserfahrung im Regulatory Affairs Umfeld für Medizinprodukte
Als Regulatory Affairs Manager übernehmen Sie Verantwortung für den regulatorischen Bereich und bringen Ihre Erfahrung dort ein, wo sie wirklich gebraucht wird. Sie möchten nicht nur technische Dokumentationen pflegen, sondern Regulatory Affairs aktiv mitgestalten? * Mehrjährige Berufserfahrung im Regulatory Affairs Umfeld für Medizinprodukte
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Leiter Produktionsentwicklung Pharma (MSAT) (m/w/d)
Leiter Produktionsentwicklung Pharma (MSAT) (m/w/d)
Adecco Personaldienstleistungen GmbH
Troisdorf bei Bonn
Teilweise Home-Office
Anschreiben nicht erforderlich
Zusammenarbeit mit Regulatory Affairs bei CMC-relevanten Fragestellungen
Zusammenarbeit mit Regulatory Affairs bei CMC-relevanten Fragestellungen
Join us as our Product Owner / Product Manager – High Acuity Care (ICU, Emergency, Anesthesia) at Dedalus, one of the World's leading healthcare technology companies, in Wien with possibility of Hybrid Working, Bonn or Trier to do the best work of your career and make a profound impact in providing better care for a healthier planet. * Analyze market trends, regulatory requirements, and customer feedback
Join us as our Product Owner / Product Manager – High Acuity Care (ICU, Emergency, Anesthesia) at Dedalus, one of the World's leading healthcare technology companies, in Wien with possibility of Hybrid Working, Bonn or Trier to do the best work of your career and make a profound impact in providing better care for a healthier planet. * Analyze market trends, regulatory requirements, and customer feedback
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Product Management Teamlead ORBIS Medical Controlling
Product Management Teamlead ORBIS Medical Controlling
Dedalus HealthCare GmbH
Bonn
Teilweise Home-Office
Analyse market needs and regulatory requirements across different regions, especially in the DACH region, to ensure the product roadmap reflects real customer and market value
Analyse market needs and regulatory requirements across different regions, especially in the DACH region, to ensure the product roadmap reflects real customer and market value
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Field Clinical Specialist TMTT, Bonn/Siegen
Field Clinical Specialist TMTT, Bonn/Siegen
Edwards Lifesciences GmbH
Bonn, Siegen
Teilweise Home-Office
Schnelle Bewerbung
Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting.
Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting.
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Schnelle Bewerbung
Erste Erfahrungen im Umgang mit Regulatory Compliance wären wünschenswertAnforderungen an den Bewerber: Grundkenntnisse: Kundenberatung, -betreuung, Systembetreuung, Systemadministration, Systemverwaltung, Hardwareinstallation, Softwareinstallation, Informationstechnik, Computertechnik
Erste Erfahrungen im Umgang mit Regulatory Compliance wären wünschenswertAnforderungen an den Bewerber: Grundkenntnisse: Kundenberatung, -betreuung, Systembetreuung, Systemadministration, Systemverwaltung, Hardwareinstallation, Softwareinstallation, Informationstechnik, Computertechnik
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Associate Director Regulatory Affairs – Clinical Lead*
Associate Director Regulatory Affairs – Clinical Lead*
Immatics Biotechnologies GmbH
Tübingen, München, Home-Office
Teilweise Home-Office
We are currently seeking an Associate Director Regulatory Affairs – Clinical Lead* to strengthen our EU Regulatory team. * Master's degree in natural sciences (e.g. Biology, Chemistry or Pharmacy) or Regulatory Affairs * 8+ years of Regulatory Affairs experience in biopharmaceuticals and/or ATMPs. In this role, you will take ownership of EU regulatory strategy and execution for innovative oncology biopharmaceutical programs, including ATMPs, across early and late-stage development. You will work in Tübingen, Munich or remote (Germany) in a highly collaborative international environment and act as key regulatory leader within cross-functional teams, ensuring clear, pragmatic, compliant and strategically aligned regulatory positioning. You will independently lead EU regulatory activities for assigned clinical programs and act as a of regulatory strategy and execution.
We are currently seeking an Associate Director Regulatory Affairs – Clinical Lead* to strengthen our EU Regulatory team. * Master's degree in natural sciences (e.g. Biology, Chemistry or Pharmacy) or Regulatory Affairs * 8+ years of Regulatory Affairs experience in biopharmaceuticals and/or ATMPs. In this role, you will take ownership of EU regulatory strategy and execution for innovative oncology biopharmaceutical programs, including ATMPs, across early and late-stage development. You will work in Tübingen, Munich or remote (Germany) in a highly collaborative international environment and act as key regulatory leader within cross-functional teams, ensuring clear, pragmatic, compliant and strategically aligned regulatory positioning. You will independently lead EU regulatory activities for assigned clinical programs and act as a of regulatory strategy and execution.
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Manager SAP Banking (m/w/d) im Team Finance, Risk and Regulatory Reporting
Manager SAP Banking (m/w/d) im Team Finance, Risk and Regulatory Reporting
x1F GmbH
bundesweit, Frankfurt, Hamburg, München, Home-Office, Österreich
Teilweise Home-Office
Schnelle Bewerbung
Als Manager SAP Banking (m/w/d) bei x1F gestaltest du als treibende Kraft wegweisende Finanzprozesse.
Als Manager SAP Banking (m/w/d) bei x1F gestaltest du als treibende Kraft wegweisende Finanzprozesse.
Senior Consultant SAP RE-FX (S/4HANA) (m/w/d) im Team Finance & Regulatory
Senior Consultant SAP RE-FX (S/4HANA) (m/w/d) im Team Finance & Regulatory
x1F GmbH
bundesweit, Düsseldorf, Frankfurt, Hamburg, Hannover, München, Home-Office
Teilweise Home-Office
Schnelle Bewerbung
x1F GmbH * bundesweit, Düsseldorf, Frankfurt, Hamburg, Hannover, München, Home-Office * Feste Anstellung * Homeoffice möglich, Vollzeit - Schnelle Bewerbung (Growing Exponentially x Together) = Success - x1F ist ein führender Anbieter integrierter Lösungen mit besonderem Fokus auf die Financial Services Industry. Wir helfen Unternehmen, ihre Geschäftsmodelle zukunftssicher aufzustellen – von der CFO-Agenda über Sustainable Finance bis hin zu digitalen Plattformstrategien. Mit rund 1.350 Mitarbeitenden an über 40 Standorten weltweit – in Europa, den USA, Kanada und Australien – erwirtschaften wir jährlich über 200 Millionen Euro Umsatz. Deine Aufgaben bei x1F - Du bringst Immobilienprozesse, Vertragsmanagement und Finanzarchitektur in Einklang. Dein Schwerpunkt liegt auf der fachlichen und technischen Umsetzung von SAP RE-FX im S/4HANA Kontext.
x1F GmbH * bundesweit, Düsseldorf, Frankfurt, Hamburg, Hannover, München, Home-Office * Feste Anstellung * Homeoffice möglich, Vollzeit - Schnelle Bewerbung (Growing Exponentially x Together) = Success - x1F ist ein führender Anbieter integrierter Lösungen mit besonderem Fokus auf die Financial Services Industry. Wir helfen Unternehmen, ihre Geschäftsmodelle zukunftssicher aufzustellen – von der CFO-Agenda über Sustainable Finance bis hin zu digitalen Plattformstrategien. Mit rund 1.350 Mitarbeitenden an über 40 Standorten weltweit – in Europa, den USA, Kanada und Australien – erwirtschaften wir jährlich über 200 Millionen Euro Umsatz. Deine Aufgaben bei x1F - Du bringst Immobilienprozesse, Vertragsmanagement und Finanzarchitektur in Einklang. Dein Schwerpunkt liegt auf der fachlichen und technischen Umsetzung von SAP RE-FX im S/4HANA Kontext.
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Senior Accountant – Germany, Belgium & France
Senior Accountant – Germany, Belgium & France
GYNEMED GmbH & Co. KG
Sierksdorf, bundesweit, Home-Office
Teilweise Home-Office
Schnelle Bewerbung
Ensure compliance with local statutory, tax, and regulatory requirements in Germany, Belgium, and France
Ensure compliance with local statutory, tax, and regulatory requirements in Germany, Belgium, and France
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• Abstimmung und Koordination von Maßnahmen in enger Zusammenarbeit mit Fachabteilungen wie Regulatory Affairs, Compliance Management, Quality Control, Engineering und globalen Teams
• Abstimmung und Koordination von Maßnahmen in enger Zusammenarbeit mit Fachabteilungen wie Regulatory Affairs, Compliance Management, Quality Control, Engineering und globalen Teams
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Schnelle Bewerbung
Hierzulande stellt das Unternehmen täglich die reibungslosen Abläufe umfassender Versorgungs- und Servicekonzepte für Unternehmen sicher, rund um Gebäude und Immobilien mit der Marke Plural und im Bereich Food, Catering und Events für Unternehmen, Gesundheitseinrichtungen, Bildungsträger und Behörden mit den Marken Eurest, Food Affairs und Medirest. Stellenangebot: Sales Manager (m/w/d)* Der Sales Manager fokussiert sich auf die Akquise und Neukundengewinnung hauptsächlich großer Business- und Industry-Unternehmen. * Der Sales Manager berichtet an den Vice President Sales Deutschland/li> Die Position des Sales Managers bei der Compass Group Deutschland bietet hohe Profilierungspotenziale für Persönlichkeiten mit strategischer Denkweise, Abschlussstärke und Freude an beratungsintensiven Themen.
Hierzulande stellt das Unternehmen täglich die reibungslosen Abläufe umfassender Versorgungs- und Servicekonzepte für Unternehmen sicher, rund um Gebäude und Immobilien mit der Marke Plural und im Bereich Food, Catering und Events für Unternehmen, Gesundheitseinrichtungen, Bildungsträger und Behörden mit den Marken Eurest, Food Affairs und Medirest. Stellenangebot: Sales Manager (m/w/d)* Der Sales Manager fokussiert sich auf die Akquise und Neukundengewinnung hauptsächlich großer Business- und Industry-Unternehmen. * Der Sales Manager berichtet an den Vice President Sales Deutschland/li> Die Position des Sales Managers bei der Compass Group Deutschland bietet hohe Profilierungspotenziale für Persönlichkeiten mit strategischer Denkweise, Abschlussstärke und Freude an beratungsintensiven Themen.
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Key Account Manager (m/w/d) Laborgeräte - international
Key Account Manager (m/w/d) Laborgeräte - international
Kempers Recruiting & Consulting GmbH
Deutschland
Schnelle Bewerbung
• Enge Abstimmung mit Produktmanagement, Engineering, Regulatory/Quality und Operations zu kundenspezifischen Anforderungen und Differenzierung gegenüber Produkten der Eigenmarke
• Enge Abstimmung mit Produktmanagement, Engineering, Regulatory/Quality und Operations zu kundenspezifischen Anforderungen und Differenzierung gegenüber Produkten der Eigenmarke
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Business Consultant Financial Services (all genders)
Business Consultant Financial Services (all genders)
adesso SE
Berlin, Hamburg, München, Köln, Frankfurt, Stuttgart, Leipzig, Dortmund
Teilweise Home-Office
Anschreiben nicht erforderlich
Kreative Beratung: Du berätst unsere Kunden strategisch zu aktuellen Herausforderungen in bankfachlichen Themenbereichen wie Digitalisierung, KI, Data Management, Regulatory Reporting (z.B. ESG) und Payments.
Kreative Beratung: Du berätst unsere Kunden strategisch zu aktuellen Herausforderungen in bankfachlichen Themenbereichen wie Digitalisierung, KI, Data Management, Regulatory Reporting (z.B. ESG) und Payments.
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Trimble is looking for a passionate, results-driven Field Marketing Manager to spearhead our market awareness and brand dominance across Germany, Austria, and Switzerland during a two-year maternity leave coverage. * Deploy sophisticated multi-channel campaigns and account-based marketing initiatives tailored to the specific business cultures, regulatory challenges, and logistics trends of the DACH region.
Trimble is looking for a passionate, results-driven Field Marketing Manager to spearhead our market awareness and brand dominance across Germany, Austria, and Switzerland during a two-year maternity leave coverage. * Deploy sophisticated multi-channel campaigns and account-based marketing initiatives tailored to the specific business cultures, regulatory challenges, and logistics trends of the DACH region.
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Actively participate and act as subject manager expert in projects and contribute your experience to process improvements to create a solution that represents the view of the back office. * Understanding of Regulatory and Quality impacts to process
Actively participate and act as subject manager expert in projects and contribute your experience to process improvements to create a solution that represents the view of the back office. * Understanding of Regulatory and Quality impacts to process