Cytokinetics
Director, Regulatory Affairs CMC(m/w/x)
Vollzeitnur vor OrtSenior
Zug
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VAVaxcyte
Executive Director, Regulatory Affairs(m/w/x)
Zug, Visp
VollzeitFreelanceVor OrtSenior
Nejo KI-Zusammenfassung
Developing clinical strategies for vaccine submissions against bacterial diseases. 15+ years industry experience, 10+ years regulatory expertise essential. Equity component.
Anforderungen
- BA or BS in clinical pharmacology, immunology, biology, medicine, bioanalytics, or related life sciences
- 15+ years industry experience demonstrating technical/regulatory expertise/competence
- Graduate education, professional certifications, or training in regulatory/quality (bonus)
- 10+ years extensive regulatory experience: submissions/approvals (pharma/biotech, vaccines/clinical)
- Thorough understanding: clinical development, statistics, vaccine development, commercialization
- Direct experience: health authority engagement (FDA, EMA, MHRA, Health Canada) and global regulatory applications
- Demonstrated ability: lead/manage cross-functional teams, develop regulatory strategies, prepare/submit clinical/pre-clinical documentation
- Direct experience: clinical regulatory strategies/submissions for global labelling/post-approval changes (commercial vaccines)
- Demonstrated record: identifying clinical/regulatory risks and developing mitigation strategies
- Experience translating/integrating regulatory intelligence into internal policies/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 global regulatory strategies for clinical studies.
- Implement global regulatory strategies for clinical studies.
- Develop global regulatory strategies for vaccine commercialization.
- Implement global regulatory strategies for vaccine commercialization.
- Provide regulatory guidance for clinical protocols.
- Facilitate preparation of clinical development protocols.
- Interpret and summarize clinical study results.
- Prepare clinical regulatory documents.
- Prepare pre-clinical regulatory documents.
- Draft correspondence to regulatory authorities.
- Prepare responses to regulatory authorities.
- Prepare investigational regulatory applications (IND/IMPD).
- Prepare commercial regulatory applications (BLA/MAA).
- Prepare post-approval clinical notifications.
- Prepare post-approval safety notifications.
- Develop regulatory CMC documentation.
- Author regulatory CMC documentation.
- Review regulatory CMC documentation.
- Prepare application documents for submission.
- Prepare correspondence for submission.
- Prepare responses to regulatory queries.
- Prepare requests for scientific advice (EU, Switzerland, UK, Canada).
- Provide regulatory guidance to cross-functional teams.
- Ensure adherence to current regulatory requirements.
- Ensure alignment with ICH guidance.
- Ensure alignment with industry best practices.
- Serve as primary contact for regulatory authorities.
- Contribute to developing product label claims.
- Contribute to developing justifications for clinical outcomes.
- Lead interactions with global regulatory authorities.
- Lead negotiations with global regulatory authorities.
- Reconcile clinical and pre-clinical issues.
- Expedite regulatory application submissions.
- Expedite regulatory approvals.
- Support safety notification requirements.
- Support pharmacovigilance notification requirements.
- Provide guidance on contemporary regulatory intelligence.
- Provide guidance on statutory legislation.
- Provide guidance on regulatory authority changes.
- Manage cross-functional teams for compliance.
- Demonstrate and ensure regulatory compliance.
- Develop and manage team members (optional).
Berufserfahrung
- 15 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Sonstige Vorteile
- Comprehensive benefits
Attraktive Vergütung
- Equity component
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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Vollzeitnur vor OrtSeniorRisch-Rotkreuz - Alnylam Pharmaceuticals, Inc.
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VAVaxcyte
Executive Director, Regulatory Affairs(m/w/x)
Zug, Visp
VollzeitFreelanceVor OrtSenior
Nejo KI-Zusammenfassung
Developing clinical strategies for vaccine submissions against bacterial diseases. 15+ years industry experience, 10+ years regulatory expertise essential. Equity component.
Anforderungen
- BA or BS in clinical pharmacology, immunology, biology, medicine, bioanalytics, or related life sciences
- 15+ years industry experience demonstrating technical/regulatory expertise/competence
- Graduate education, professional certifications, or training in regulatory/quality (bonus)
- 10+ years extensive regulatory experience: submissions/approvals (pharma/biotech, vaccines/clinical)
- Thorough understanding: clinical development, statistics, vaccine development, commercialization
- Direct experience: health authority engagement (FDA, EMA, MHRA, Health Canada) and global regulatory applications
- Demonstrated ability: lead/manage cross-functional teams, develop regulatory strategies, prepare/submit clinical/pre-clinical documentation
- Direct experience: clinical regulatory strategies/submissions for global labelling/post-approval changes (commercial vaccines)
- Demonstrated record: identifying clinical/regulatory risks and developing mitigation strategies
- Experience translating/integrating regulatory intelligence into internal policies/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 global regulatory strategies for clinical studies.
- Implement global regulatory strategies for clinical studies.
- Develop global regulatory strategies for vaccine commercialization.
- Implement global regulatory strategies for vaccine commercialization.
- Provide regulatory guidance for clinical protocols.
- Facilitate preparation of clinical development protocols.
- Interpret and summarize clinical study results.
- Prepare clinical regulatory documents.
- Prepare pre-clinical regulatory documents.
- Draft correspondence to regulatory authorities.
- Prepare responses to regulatory authorities.
- Prepare investigational regulatory applications (IND/IMPD).
- Prepare commercial regulatory applications (BLA/MAA).
- Prepare post-approval clinical notifications.
- Prepare post-approval safety notifications.
- Develop regulatory CMC documentation.
- Author regulatory CMC documentation.
- Review regulatory CMC documentation.
- Prepare application documents for submission.
- Prepare correspondence for submission.
- Prepare responses to regulatory queries.
- Prepare requests for scientific advice (EU, Switzerland, UK, Canada).
- Provide regulatory guidance to cross-functional teams.
- Ensure adherence to current regulatory requirements.
- Ensure alignment with ICH guidance.
- Ensure alignment with industry best practices.
- Serve as primary contact for regulatory authorities.
- Contribute to developing product label claims.
- Contribute to developing justifications for clinical outcomes.
- Lead interactions with global regulatory authorities.
- Lead negotiations with global regulatory authorities.
- Reconcile clinical and pre-clinical issues.
- Expedite regulatory application submissions.
- Expedite regulatory approvals.
- Support safety notification requirements.
- Support pharmacovigilance notification requirements.
- Provide guidance on contemporary regulatory intelligence.
- Provide guidance on statutory legislation.
- Provide guidance on regulatory authority changes.
- Manage cross-functional teams for compliance.
- Demonstrate and ensure regulatory compliance.
- Develop and manage team members (optional).
Berufserfahrung
- 15 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Sonstige Vorteile
- Comprehensive benefits
Attraktive Vergütung
- Equity component
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.
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
Director, Regulatory Affairs CMC(m/w/x)
Vollzeitnur vor OrtSeniorZug - Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Vollzeitnur vor OrtSeniorRisch-Rotkreuz - Alnylam Pharmaceuticals, Inc.
Associate Director, Regulatory Affairs(m/w/x)
Vollzeitnur vor OrtSeniorZug - Cytokinetics
Compliance Director, Europe(m/w/x)
Vollzeitnur vor OrtSeniorZug - Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Vollzeitnur vor OrtSeniorRisch-Rotkreuz