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Head, Launch Acceleration & Regulatory Enablement - Global Launch Center(m/w/x)
Accelerating regulatory dossier submissions for new biopharma products, integrating readiness into portfolio planning. 10-15+ years in Global Regulatory Affairs with enterprise transformation leadership required. Flexible working options in an AI-powered biopharma environment.
Anforderungen
- Advanced degree in Life Sciences, Pharmacy, or related field preferred
- 10–15+ years of progressive experience in Global Regulatory Affairs
- Expertise in CTD/eCTD submissions and global regulatory frameworks
- Success leading enterprise-level transformation or operating-model redesign
- Outside-in thinker with ability to translate best practices
- Strong executive presence and influence skills
- Ability to thrive in ambiguity and build-as-you-scale environments
- Bias for action, experimentation, and measurable outcomes
- Patient-first and science-driven mindset
- Fluency in English
Aufgaben
- Define a next-generation dossier acceleration strategy
- Design and implement scalable dossier operating models
- Integrate acceleration principles into portfolio planning
- Embed dossier readiness upstream in development
- Execute activities managed by the launch acceleration team
- Translate agile and digital concepts into dossier models
- Lead rapid experimentation through pilots and proof-of-concepts
- Champion modern, asset-centric regulatory thinking
- Challenge legacy regulatory assumptions
- Establish a modular regulatory backbone for content reuse
- Drive adoption of global core dossiers
- Ensure consistent messaging across all regulatory content
- Identify bottlenecks and simplify dossier workflows
- Set global standards for planning and quality checkpoints
- Partner with digital teams to enable automation
- Influence senior leaders as an enterprise change agent
- Lead effectively within a highly matrixed environment
- Provide escalation pathways to maintain critical paths
- Ensure built-in quality and compliance standards
- Establish metrics to monitor speed and predictability
- Strengthen inspection readiness and documentation rigor
- Build and mentor a high-performing acceleration team
- Define future-ready regulatory capabilities
- Serve as a thought leader across Regulatory Affairs
Berufserfahrung
- 10 - 15 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- CTD
- eCTD
Benefits
Flexibles Arbeiten
- Flexible working options
Gesundheits- & Fitnessangebote
- Comprehensive healthcare
Mentale Gesundheitsförderung
- Well-being programs
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Head, Launch Acceleration & Regulatory Enablement - Global Launch Center(m/w/x)
Accelerating regulatory dossier submissions for new biopharma products, integrating readiness into portfolio planning. 10-15+ years in Global Regulatory Affairs with enterprise transformation leadership required. Flexible working options in an AI-powered biopharma environment.
Anforderungen
- Advanced degree in Life Sciences, Pharmacy, or related field preferred
- 10–15+ years of progressive experience in Global Regulatory Affairs
- Expertise in CTD/eCTD submissions and global regulatory frameworks
- Success leading enterprise-level transformation or operating-model redesign
- Outside-in thinker with ability to translate best practices
- Strong executive presence and influence skills
- Ability to thrive in ambiguity and build-as-you-scale environments
- Bias for action, experimentation, and measurable outcomes
- Patient-first and science-driven mindset
- Fluency in English
Aufgaben
- Define a next-generation dossier acceleration strategy
- Design and implement scalable dossier operating models
- Integrate acceleration principles into portfolio planning
- Embed dossier readiness upstream in development
- Execute activities managed by the launch acceleration team
- Translate agile and digital concepts into dossier models
- Lead rapid experimentation through pilots and proof-of-concepts
- Champion modern, asset-centric regulatory thinking
- Challenge legacy regulatory assumptions
- Establish a modular regulatory backbone for content reuse
- Drive adoption of global core dossiers
- Ensure consistent messaging across all regulatory content
- Identify bottlenecks and simplify dossier workflows
- Set global standards for planning and quality checkpoints
- Partner with digital teams to enable automation
- Influence senior leaders as an enterprise change agent
- Lead effectively within a highly matrixed environment
- Provide escalation pathways to maintain critical paths
- Ensure built-in quality and compliance standards
- Establish metrics to monitor speed and predictability
- Strengthen inspection readiness and documentation rigor
- Build and mentor a high-performing acceleration team
- Define future-ready regulatory capabilities
- Serve as a thought leader across Regulatory Affairs
Berufserfahrung
- 10 - 15 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- CTD
- eCTD
Benefits
Flexibles Arbeiten
- Flexible working options
Gesundheits- & Fitnessangebote
- Comprehensive healthcare
Mentale Gesundheitsförderung
- Well-being programs
Über das Unternehmen
Sanofi International AG
Branche
Pharmaceuticals
Beschreibung
Sanofi is an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth through innovative medicines and vaccines.
Noch nicht perfekt?
- Sanofi International AG
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Vollzeitnur vor OrtSeniorBaar - Roche Diagnostics Int. AG
Head Environmental Regulatory Affairs(m/w/x)
Vollzeitnur vor OrtSeniorRisch-Rotkreuz - Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Vollzeitnur vor OrtSeniorRisch-Rotkreuz - Sanofi International AG
Global Head of Strategic Projects and Portfolio Management EM&S – Global Launch Center(m/w/x)
Vollzeitnur vor OrtSeniorRisch-Rotkreuz