CSL Plasma
GRA CMC Manager(m/w/x)
Vollzeitnur vor OrtSenior
Bern
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
Global CMC regulatory strategies for biotherapeutics, focusing on immunology and hematology. University degree in natural sciences required. Well-being support.
Anforderungen
- University degree in natural sciences or equivalent
- Degree in Regulatory Affairs is advantageous
- Sound knowledge in natural sciences
- Focus on biological medicinal products
- Basic knowledge of regulatory framework (US, EU, Japan, CH, Australia)
- Excellent communication skills
- Excellent project management skills
- Excellent planning skills
- Excellent problem-solving skills
- Excellent presentation skills
- Strong team player
- Ability to develop constructive relationships
- Ability to develop effective relationships with peers and management
- Strong organizational skills
- Strong follow-up skills
- Attention to detail
- Ability to work with minimal supervision
- Sound technical judgment
- Sound analytical judgment
- Flexibility for global cross-cultural work
- Microsoft Office skills
- Fluent English
- Fluent local language
Aufgaben
- Lead global CMC regulatory strategies
- Ensure compliant execution of submissions and changes
- Partner with technical and regulatory teams worldwide
- Drive CMC strategies for clinical trials and product licenses
- Assess and manage CMC, facility, and plasma changes
- Serve as primary regulatory liaison with technical experts
- Support GMP inspections and inspection readiness
- Interpret regulatory guidelines and prepare impact assessments
- Contribute to process improvements
- Provide technical guidance to CMC Scientists
- Deputize for the CMC Team Lead
- Maintain content of relevant regulatory dossiers
- Prepare and review Module 2.3 and Module 3 documents
- Compile facility and equipment information for new product registrations
- Author technical narratives and CMC documentation
- Respond to CMC-related Health Authority questions
- Compile CMC information for CTAs, INDs, and other submissions
- Support timely and compliant regulatory assessments
- Execute CMC changes efficiently
- Prepare CMC information for tenders, PSURs, DSURs, and promotional materials
- Contribute to annual product quality reviews and risk assessments
- Participate in Global Regulatory Affairs Strategy Teams
- Represent Global Regulatory Affairs in CMC project teams
- Develop and implement global CMC regulatory strategies
- Evaluate technical and scientific CMC information for compliance
- Perform gap analysis and propose solutions
- Support scheduling and prioritization of CMC submissions
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- local – verhandlungssicher
Tools & Technologien
- Microsoft Office
Benefits
Mentale Gesundheitsförderung
- Well-being support
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CSL Behring erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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Global CMC regulatory strategies for biotherapeutics, focusing on immunology and hematology. University degree in natural sciences required. Well-being support.
Anforderungen
- University degree in natural sciences or equivalent
- Degree in Regulatory Affairs is advantageous
- Sound knowledge in natural sciences
- Focus on biological medicinal products
- Basic knowledge of regulatory framework (US, EU, Japan, CH, Australia)
- Excellent communication skills
- Excellent project management skills
- Excellent planning skills
- Excellent problem-solving skills
- Excellent presentation skills
- Strong team player
- Ability to develop constructive relationships
- Ability to develop effective relationships with peers and management
- Strong organizational skills
- Strong follow-up skills
- Attention to detail
- Ability to work with minimal supervision
- Sound technical judgment
- Sound analytical judgment
- Flexibility for global cross-cultural work
- Microsoft Office skills
- Fluent English
- Fluent local language
Aufgaben
- Lead global CMC regulatory strategies
- Ensure compliant execution of submissions and changes
- Partner with technical and regulatory teams worldwide
- Drive CMC strategies for clinical trials and product licenses
- Assess and manage CMC, facility, and plasma changes
- Serve as primary regulatory liaison with technical experts
- Support GMP inspections and inspection readiness
- Interpret regulatory guidelines and prepare impact assessments
- Contribute to process improvements
- Provide technical guidance to CMC Scientists
- Deputize for the CMC Team Lead
- Maintain content of relevant regulatory dossiers
- Prepare and review Module 2.3 and Module 3 documents
- Compile facility and equipment information for new product registrations
- Author technical narratives and CMC documentation
- Respond to CMC-related Health Authority questions
- Compile CMC information for CTAs, INDs, and other submissions
- Support timely and compliant regulatory assessments
- Execute CMC changes efficiently
- Prepare CMC information for tenders, PSURs, DSURs, and promotional materials
- Contribute to annual product quality reviews and risk assessments
- Participate in Global Regulatory Affairs Strategy Teams
- Represent Global Regulatory Affairs in CMC project teams
- Develop and implement global CMC regulatory strategies
- Evaluate technical and scientific CMC information for compliance
- Perform gap analysis and propose solutions
- Support scheduling and prioritization of CMC submissions
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- local – verhandlungssicher
Tools & Technologien
- Microsoft Office
Benefits
Mentale Gesundheitsförderung
- Well-being support
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CSL Behring erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
CSL Behring
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
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