Sanofi International AG
Head of M&S SpeCare Strategy – Global Launch Center(m/w/x)
Full-timeOn-siteSenior
Risch-Rotkreuz
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SASanofi International AG
Head, Launch Acceleration & Regulatory Enablement - Global Launch Center(m/w/x)
Risch-Rotkreuz
Full-timeOn-siteSenior
AI/ML
Data Science
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 10 - 15 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- CTD
- eCTD
Benefits
Flexible Working
- Flexible working options
Healthcare & Fitness
- Comprehensive healthcare
Mental Health Support
- Well-being programs
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sanofi International AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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SASanofi International AG
Head, Launch Acceleration & Regulatory Enablement - Global Launch Center(m/w/x)
Risch-Rotkreuz
Full-timeOn-siteSenior
AI/ML
Data Science
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 10 - 15 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- CTD
- eCTD
Benefits
Flexible Working
- Flexible working options
Healthcare & Fitness
- Comprehensive healthcare
Mental Health Support
- Well-being programs
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sanofi International AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Sanofi International AG
Industry
Pharmaceuticals
Description
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.
Not a perfect match?
- Sanofi International AG
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Head Environmental Regulatory Affairs(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Sanofi International AG
Global Head of Strategic Projects and Portfolio Management EM&S – Global Launch Center(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz