Takeda Pharmaceuticals International AG
Manager, International Clinical Trial Regulatory Lead(m/w/x)
Vollzeitnur vor OrtManagement
Zürich
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
CSCSL Behring
Manager, Regulatory Clinical Trial Authorization (CTA)(m/w/x)
Glattbrugg
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Translating global CTA strategies into study-level regulatory approaches for biotherapeutics. Minimum 5 years managing Clinical Trial Authorizations required. Well-being support.
Anforderungen
- Degree (BSc/MSc) or equivalent in life science, pharmacy, or health/medical field
- Minimum 5 years managing Clinical Trial Authorizations
- Strong experience with CTA requirements and processes, including EU CTR
- Experience working with or overseeing external vendors/CROs
- Extensive knowledge of ICH guidelines/GCP and current medical/scientific/regulatory knowledge incl. inspection expectation
- Demonstrated problem-solving and judgment in regulatory matters
- Strong regulatory judgment within defined strategic frameworks
- Structured, risk-based oversight mindset
- Ability to manage complexity and priorities in a matrix environment
- Clear communication and issue escalation skills
- Quality and compliance-focused approach
- Customer service focus
- Excellent written and oral communication skills in English
- Maintains computer literacy in appropriate software
Aufgaben
- Translate global CTA strategies into study-level regulatory approaches
- Align regulatory approaches with development priorities and requirements
- Provide CTA guidance to external service providers and Study Teams
- Support early risk-based CTA planning for critical studies
- Identify country approach, sequencing, and regulatory sensitivities
- Ensure consistent application of regulatory intelligence
- Act as internal CTA interface for assigned clinical studies
- Provide cross-functional coordination and governance oversight
- Serve as primary oversight contact for external partners
- Execute risk-based oversight activities
- Monitor vendor performance against KPIs, timelines, and quality
- Contribute to joint improvement initiatives with partners
- Ensure compliance with GCP requirements and internal procedures
- Prepare for Health Authority inspections and audits
- Participate as internal CTA representative in inspections
- Escalate compliance risks and propose mitigation actions
- Adhere to CTA processes and working practices
- Identify and address process inefficiencies and quality issues
- Drive improvement actions for CTA delivery and oversight
- Implement approved process changes, tools, and templates
- Contribute to CTA metrics, dashboards, and reporting
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
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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Manager, Regulatory Clinical Trial Authorization (CTA)(m/w/x)
Glattbrugg
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Translating global CTA strategies into study-level regulatory approaches for biotherapeutics. Minimum 5 years managing Clinical Trial Authorizations required. Well-being support.
Anforderungen
- Degree (BSc/MSc) or equivalent in life science, pharmacy, or health/medical field
- Minimum 5 years managing Clinical Trial Authorizations
- Strong experience with CTA requirements and processes, including EU CTR
- Experience working with or overseeing external vendors/CROs
- Extensive knowledge of ICH guidelines/GCP and current medical/scientific/regulatory knowledge incl. inspection expectation
- Demonstrated problem-solving and judgment in regulatory matters
- Strong regulatory judgment within defined strategic frameworks
- Structured, risk-based oversight mindset
- Ability to manage complexity and priorities in a matrix environment
- Clear communication and issue escalation skills
- Quality and compliance-focused approach
- Customer service focus
- Excellent written and oral communication skills in English
- Maintains computer literacy in appropriate software
Aufgaben
- Translate global CTA strategies into study-level regulatory approaches
- Align regulatory approaches with development priorities and requirements
- Provide CTA guidance to external service providers and Study Teams
- Support early risk-based CTA planning for critical studies
- Identify country approach, sequencing, and regulatory sensitivities
- Ensure consistent application of regulatory intelligence
- Act as internal CTA interface for assigned clinical studies
- Provide cross-functional coordination and governance oversight
- Serve as primary oversight contact for external partners
- Execute risk-based oversight activities
- Monitor vendor performance against KPIs, timelines, and quality
- Contribute to joint improvement initiatives with partners
- Ensure compliance with GCP requirements and internal procedures
- Prepare for Health Authority inspections and audits
- Participate as internal CTA representative in inspections
- Escalate compliance risks and propose mitigation actions
- Adhere to CTA processes and working practices
- Identify and address process inefficiencies and quality issues
- Drive improvement actions for CTA delivery and oversight
- Implement approved process changes, tools, and templates
- Contribute to CTA metrics, dashboards, and reporting
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
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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