Launch Acceleration and Regulatory Enablement Lead
Core
Lead submission acceleration initiatives and build a new function to transform how Sanofi conceives, builds, and delivers regulatory submissions to accelerate bringing medicines to patients.
Role type
Senior IC regulatory strategy and process innovation lead
Builds
A new global regulatory submission acceleration function, tools, templates, and a Submission Excellence Platform
Domain
Biopharmaceuticals / Global Regulatory Affairs
Required skills
Global regulatory strategy, submission acceleration, change management, training delivery, modular dossier architecture, process innovation, cross-functional stakeholder management, quality metrics tracking
Preferred skills
Advanced degree (MSc, PhD, PharmD), AI/automation tool familiarity, agile methodologies, outside-in thinking from high-velocity industries
Technologies
CTD modules, core dossier sections, bridging documents, Submission Excellence Platform, AI tools, automation tools
Responsibilities
Develop submission acceleration strategies and best practices; design and deliver training on new processes; modernize modular regulatory content; monitor regulatory intelligence and industry best practices; co-design process pilots and adopt AI/automation; serve as a cross-functional partner for R&D teams
Seniority
Senior, hands-on IC with strategic influence