Head, Launch Acceleration & Regulatory Enablement - Global Launch Center(m/w/x)

Beschreibung

You will transform regulatory operations by designing high-velocity dossier models that accelerate product launches. In this leadership role, you'll drive enterprise-wide change and use digital innovation to ensure global compliance.

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

Tools & Technologien

Benefits