Cytokinetics
Director, Regulatory Affairs CMC(m/w/x)
Vollzeitnur vor OrtSenior
Zug
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
VAVaxcyte
Executive Director, Regulatory Affairs – Clinical European/Global Focus(m/w/x)
Zug, Visp
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Global clinical regulatory strategy development and CMC documentation authoring for vaccine innovation. 15+ years industry experience required, graduate education a plus. Equity component, comprehensive benefits.
Anforderungen
- BA or BS in relevant scientific/technical discipline (clinical pharmacology, immunology, biology, medicine, bioanalytics, life sciences)
- 15+ years industry experience demonstrating technical and regulatory expertise
- Graduate education or professional certifications/training in regulatory/quality (bonus)
- Alternative combinations of education/experience considered
- 10+ years extensive regulatory experience in pharma/biotech
- Proven record developing/prosecuting regulatory submissions/approvals
- Emphasis on vaccines and clinical content
- Thorough understanding of clinical development and statistics
- Particular experience with vaccine development and commercialization
- Direct experience engaging multiple health authorities (FDA, EMA, MHRA, Health Canada)
- Preparation of regulatory applications for global health authorities
- Demonstrated ability to lead/manage cross-functional teams
- Developing/establishing regulatory strategies
- Preparing regulatory applications (clinical/pre-clinical)
- Direct experience developing clinical regulatory strategies and submissions
- Effectively manage labelling for global markets
- Manage post-approval changes/optimizations for commercial vaccines
- Demonstrated record identifying clinical/regulatory risks
- Developing strategies/contingencies for risk mitigation
- Experience translating/integrating contemporary regulatory intelligence
- Integrating intelligence into internal policies and practice
- Articulate oral and written communication skills
- Active listening skills
- Strategic and tactical critical thinking
- Constructive operational productivity
- Adaptability
- Flexible and optimistic demeanor
Aufgaben
- Develop and execute global clinical regulatory strategies
- Author and review regulatory CMC documentation for submissions
- Provide regulatory guidance to cross-functional development teams
- Ensure compliance with current regulatory requirements and guidance
- Serve as primary contact with regulatory authorities
- Contribute to product label claims and clinical outcome justifications
- Lead negotiations with global regulatory authorities
- Support safety and pharmacovigilance notifications
- Provide updates on regulatory intelligence and legislation changes
- Manage cross-functional teams for regulatory compliance
- Develop and manage people (optional)
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Attraktive Vergütung
- Competitive compensation
- Equity component
Sonstige Vorteile
- Comprehensive benefits
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Vaxcyte 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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VAVaxcyte
Executive Director, Regulatory Affairs – Clinical European/Global Focus(m/w/x)
Zug, Visp
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Global clinical regulatory strategy development and CMC documentation authoring for vaccine innovation. 15+ years industry experience required, graduate education a plus. Equity component, comprehensive benefits.
Anforderungen
- BA or BS in relevant scientific/technical discipline (clinical pharmacology, immunology, biology, medicine, bioanalytics, life sciences)
- 15+ years industry experience demonstrating technical and regulatory expertise
- Graduate education or professional certifications/training in regulatory/quality (bonus)
- Alternative combinations of education/experience considered
- 10+ years extensive regulatory experience in pharma/biotech
- Proven record developing/prosecuting regulatory submissions/approvals
- Emphasis on vaccines and clinical content
- Thorough understanding of clinical development and statistics
- Particular experience with vaccine development and commercialization
- Direct experience engaging multiple health authorities (FDA, EMA, MHRA, Health Canada)
- Preparation of regulatory applications for global health authorities
- Demonstrated ability to lead/manage cross-functional teams
- Developing/establishing regulatory strategies
- Preparing regulatory applications (clinical/pre-clinical)
- Direct experience developing clinical regulatory strategies and submissions
- Effectively manage labelling for global markets
- Manage post-approval changes/optimizations for commercial vaccines
- Demonstrated record identifying clinical/regulatory risks
- Developing strategies/contingencies for risk mitigation
- Experience translating/integrating contemporary regulatory intelligence
- Integrating intelligence into internal policies and practice
- Articulate oral and written communication skills
- Active listening skills
- Strategic and tactical critical thinking
- Constructive operational productivity
- Adaptability
- Flexible and optimistic demeanor
Aufgaben
- Develop and execute global clinical regulatory strategies
- Author and review regulatory CMC documentation for submissions
- Provide regulatory guidance to cross-functional development teams
- Ensure compliance with current regulatory requirements and guidance
- Serve as primary contact with regulatory authorities
- Contribute to product label claims and clinical outcome justifications
- Lead negotiations with global regulatory authorities
- Support safety and pharmacovigilance notifications
- Provide updates on regulatory intelligence and legislation changes
- Manage cross-functional teams for regulatory compliance
- Develop and manage people (optional)
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Attraktive Vergütung
- Competitive compensation
- Equity component
Sonstige Vorteile
- Comprehensive benefits
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Vaxcyte 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
Vaxcyte
Branche
Pharmaceuticals
Beschreibung
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases.
Noch nicht perfekt?
- Cytokinetics
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