Roche Diagnostics GmbH
Chapter Lead International Regulatory Affairs(m/w/x)
Full-timeOn-siteManagement
Penzberg
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RORoche Diagnostics GmbH
Regulatory Affairs Project Manager(m/w/x)
Penzberg
Full-timeOn-siteSenior
Data Science
Nejo AI Summary
Product approvals and lifecycle management for disease prevention and healthcare access. 5+ years experience in healthcare product approval and compliance required. Strategic cross-functional collaboration, complex submission dossiers.
Requirements
- Degree in Life Science, Data Science, or comparable qualification
- Minimum 5 years professional experience in relevant environments
- Foundational experience in Healthcare Regulatory Affairs
- Understanding of global regulatory landscape
- Track Record in IVD or Pharma Regulatory (plus)
- Experience managing high-complexity workflows or global projects
- Ability to work independently and drive results
- Business fluent English skills
- Ability to interpret regulatory frameworks
- Self-motivated problem solver with compliance focus
- Bachelor- oder Master-Abschluss oder vergleichbare Qualifikation
- Mindestens 5 Jahre Berufserfahrung im relevanten Umfeld
- Fundierte Erfahrung in Regulatory Affairs im Gesundheitswesen
- Verständnis für globale regulatorische Umfelder
- Erfahrung in der Verwaltung hochkomplexer Arbeitsabläufe
- Verhandlungssichere Englischkenntnisse
- Fähigkeit zur Interpretation regulatorischer Rahmenbedingungen
Tasks
- Lead product approvals and lifecycle management
- Coordinate strategic cross-functional collaboration
- Ensure timely delivery of submission-ready documentation
- Maintain global regulatory compliance
- Develop and oversee complex submission dossiers
- Execute accurate global product registrations
- Share experience to enhance team expertise
- Design innovative strategies for product access
- Build relationships with internal and external stakeholders
- Integrate regulatory needs into company strategy
- Foster an inclusive environment using VACC principles
- Troubleshoot issues and implement cost-effective solutions
Work Experience
- 5 years
Education
- Vocational certificationOR
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- IVD Regulatory
- Pharma Regulatory
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche Diagnostics GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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RORoche Diagnostics GmbH
Regulatory Affairs Project Manager(m/w/x)
Penzberg
Full-timeOn-siteSenior
Data Science
Nejo AI Summary
Product approvals and lifecycle management for disease prevention and healthcare access. 5+ years experience in healthcare product approval and compliance required. Strategic cross-functional collaboration, complex submission dossiers.
Requirements
- Degree in Life Science, Data Science, or comparable qualification
- Minimum 5 years professional experience in relevant environments
- Foundational experience in Healthcare Regulatory Affairs
- Understanding of global regulatory landscape
- Track Record in IVD or Pharma Regulatory (plus)
- Experience managing high-complexity workflows or global projects
- Ability to work independently and drive results
- Business fluent English skills
- Ability to interpret regulatory frameworks
- Self-motivated problem solver with compliance focus
- Bachelor- oder Master-Abschluss oder vergleichbare Qualifikation
- Mindestens 5 Jahre Berufserfahrung im relevanten Umfeld
- Fundierte Erfahrung in Regulatory Affairs im Gesundheitswesen
- Verständnis für globale regulatorische Umfelder
- Erfahrung in der Verwaltung hochkomplexer Arbeitsabläufe
- Verhandlungssichere Englischkenntnisse
- Fähigkeit zur Interpretation regulatorischer Rahmenbedingungen
Tasks
- Lead product approvals and lifecycle management
- Coordinate strategic cross-functional collaboration
- Ensure timely delivery of submission-ready documentation
- Maintain global regulatory compliance
- Develop and oversee complex submission dossiers
- Execute accurate global product registrations
- Share experience to enhance team expertise
- Design innovative strategies for product access
- Build relationships with internal and external stakeholders
- Integrate regulatory needs into company strategy
- Foster an inclusive environment using VACC principles
- Troubleshoot issues and implement cost-effective solutions
Work Experience
- 5 years
Education
- Vocational certificationOR
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- IVD Regulatory
- Pharma Regulatory
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche Diagnostics GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Roche Diagnostics GmbH
Industry
Healthcare
Description
Das Unternehmen setzt sich dafür ein, Krankheiten zu verhindern, zu stoppen und zu heilen, und gewährleistet den Zugang zur Gesundheitsversorgung.
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