Regulatory Launch Architect & Acceleration Lead

Sanofi; Cambridge (MA); On-site; USD 180,000 - 280,000; Full time

Job summary

Sanofi is seeking a Launch Acceleration and Regulatory Enablement Lead to transform how regulatory submissions are conceived, built, and delivered. You will lead a brand-new function across Global Business Units and collaborate with cross-functional R&D teams to accelerate authorizations in a fast-moving environment.

Based in Morristown, NJ or Cambridge, MA, you will be a thought leader who defines best practices, creates tools and templates, and trains teams to adopt new workflows.

Responsibilities

• Lead submission acceleration strategies across cross-functional R&D and regulatory teams.
• Design and deliver engaging training on submission acceleration tools, processes, and mindset shifts.
• Drive strategies for modernising modular regulatory content components (CTD modules, core dossier sections).
• Monitor evolving regulatory expectations and translate external intelligence into actionable insights for teams.
• Co-design pilots and roll out improved regulatory processes and operating models.

Job description

Sanofi is seeking a Launch Acceleration and Regulatory Enablement Lead to transform how regulatory submissions are conceived, built, and delivered. You will lead a brand-new function across Global Business Units and collaborate with cross-functional R&D teams to accelerate authorizations in a fast-moving environment.

Based in Morristown, NJ or Cambridge, MA, you will be a thought leader who defines best practices, creates tools and templates, and trains teams to adopt new workflows.