Novartis
Manager, Regulatory Affairs Cell & Gene Therapies(m/w/x)
Vollzeitmit HomeofficeManagement
Schaftenau
ab 65.605,54 / Jahr
Neuer Job?Nejo!
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NONovartis
Manager, Regulatory Affairs Cell & Gene Therapies(m/w/x)
Schaftenau
ab 65.605,54 / Jahr
Vollzeitmit HomeofficeManagement
Nejo KI-Zusammenfassung
Global CMC regulatory strategy for cell and gene therapy projects, authoring health authority documentation at pharmaceutical company with 100,000+ employees. 2+ years regulatory CMC or pharmaceutical experience, critical scientific data evaluation ability required. On-site childcare facilities.
Anforderungen
- Science degree or equivalent
- At least 2 years' regulatory CMC or pharmaceutical experience
- Knowledge of chemistry, analytics, or pharmaceutical technology
- Knowledge of regulations and product life cycle maintenance
- Ability to critically evaluate scientific data
- Change Control and Regulatory Compliance skills
- Risk Assessment and Risk Management skills
- Documentation Management and Negotiation Skills
- Experience with Waterfall Model and Cross-Functional Teams
Aufgaben
- Lead global CMC regulatory strategies for cell and gene therapy projects
- Balance business benefits with regulatory compliance through innovative approaches
- Coordinate and implement global CMC submission activities
- Plan and author high-quality regulatory documentation for health authorities
- Identify and resolve issues regarding submission content, quality, or timelines
- Negotiate the delivery of technical source documents
- Ensure technical congruency and compliance with e-publishing requirements
- Communicate regulatory risks and strategies to cross-functional project teams
- Perform risk management assessments and share lessons learned from major submissions
- Lead interactions and negotiations with Health Authorities
Berufserfahrung
- 2 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Waterfall Model
Benefits
Attraktive Vergütung
- Market-competitive base salary
Boni & Prämien
- Attractive incentive program
Betriebliche Altersvorsorge
- Modern company pension scheme
Kinderbetreuung
- Childcare facilities
Weiterbildungsangebote
- Learning and development options
Karriere- und Weiterentwicklung
- Worldwide career opportunities
Sonstige Vorteile
- Recruitment process adjustments
- Disability representative involvement
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis 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.
Noch nicht perfekt?
- Novartis
Manager, Regulatory Affairs CMC(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenSchaftenauab 65.605,54 / Jahr - Novartis
Senior Manager, Regulatory Affairs CMC(m/w/x)
Vollzeitmit HomeofficeSeniorSchaftenauab 65.605,54 / Jahr - Novartis
Senior Manager, Regulatory Affairs CMC(m/w/x)
Vollzeitmit HomeofficeSeniorSchaftenauab 65.605,54 / Jahr - Novartis
Associate Director, Regulatory Affairs CMC(m/w/x)
Vollzeitmit HomeofficeSeniorSchaftenauab 78.383,9 / Jahr
NONovartis
Manager, Regulatory Affairs Cell & Gene Therapies(m/w/x)
Schaftenau
ab 65.605,54 / Jahr
Vollzeitmit HomeofficeManagement
Nejo KI-Zusammenfassung
Global CMC regulatory strategy for cell and gene therapy projects, authoring health authority documentation at pharmaceutical company with 100,000+ employees. 2+ years regulatory CMC or pharmaceutical experience, critical scientific data evaluation ability required. On-site childcare facilities.
Anforderungen
- Science degree or equivalent
- At least 2 years' regulatory CMC or pharmaceutical experience
- Knowledge of chemistry, analytics, or pharmaceutical technology
- Knowledge of regulations and product life cycle maintenance
- Ability to critically evaluate scientific data
- Change Control and Regulatory Compliance skills
- Risk Assessment and Risk Management skills
- Documentation Management and Negotiation Skills
- Experience with Waterfall Model and Cross-Functional Teams
Aufgaben
- Lead global CMC regulatory strategies for cell and gene therapy projects
- Balance business benefits with regulatory compliance through innovative approaches
- Coordinate and implement global CMC submission activities
- Plan and author high-quality regulatory documentation for health authorities
- Identify and resolve issues regarding submission content, quality, or timelines
- Negotiate the delivery of technical source documents
- Ensure technical congruency and compliance with e-publishing requirements
- Communicate regulatory risks and strategies to cross-functional project teams
- Perform risk management assessments and share lessons learned from major submissions
- Lead interactions and negotiations with Health Authorities
Berufserfahrung
- 2 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Waterfall Model
Benefits
Attraktive Vergütung
- Market-competitive base salary
Boni & Prämien
- Attractive incentive program
Betriebliche Altersvorsorge
- Modern company pension scheme
Kinderbetreuung
- Childcare facilities
Weiterbildungsangebote
- Learning and development options
Karriere- und Weiterentwicklung
- Worldwide career opportunities
Sonstige Vorteile
- Recruitment process adjustments
- Disability representative involvement
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis 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.
Über das Unternehmen
Novartis
Branche
Pharmaceuticals
Beschreibung
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Noch nicht perfekt?
- Novartis
Manager, Regulatory Affairs Cell & Gene Therapies(m/w/x)
Vollzeitmit HomeofficeManagementSchaftenauab 65.605,54 / Jahr - Novartis
Manager, Regulatory Affairs CMC(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenSchaftenauab 65.605,54 / Jahr - Novartis
Senior Manager, Regulatory Affairs CMC(m/w/x)
Vollzeitmit HomeofficeSeniorSchaftenauab 65.605,54 / Jahr - Novartis
Senior Manager, Regulatory Affairs CMC(m/w/x)
Vollzeitmit HomeofficeSeniorSchaftenauab 65.605,54 / Jahr - Novartis
Associate Director, Regulatory Affairs CMC(m/w/x)
Vollzeitmit HomeofficeSeniorSchaftenauab 78.383,9 / Jahr