Global Regulatory Launch Accelerator Lead

Sanofi; New Jersey; On-site; USD 206,000 - 298,000; Full time

Job summary

Sanofi is seeking a Launch Acceleration and Regulatory Enablement Lead to shape a new regulatory function. This role leads acceleration initiatives across Global Regulatory and R&D, defining end-to-end best practices and embedding acceleration principles early in development.

You will design training, drive modular content standardization, and partner with cross-functional teams to modernize submission workflows, applying AI and digital tools to improve speed and quality.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 10+ years of Global Regulatory Affairs experience leading global submission preparation and execution.
• Experience with lifecycle management submissions across regions (variations, renewals, line extensions).
• Familiarity with modular dossier architecture and content reuse strategies.
• Ability to work in matrixed, cross-functional environments and lead without direct authority.

Responsibilities

• Lead submission acceleration strategies across Global Regulatory and R&D teams.
• Design and deliver training on submission acceleration tools and processes.
• Drive standards for modular regulatory content components and content reuse.
• Monitor regulatory intelligence and translate into actionable insights.
• Co-design pilots and implement faster, higher-quality processes with AI/digital tools.
• Collaborate with cross-functional partners and present to senior leadership.

Skills

Global Regulatory Strategy

Training & Facilitation

Executive Presence

Cross-functional partnership

Regulatory Intelligence

Education

Bachelor's degree in Life Sciences or related field

Advanced degree (MSc, PhD, PharmD) preferred

Tools

Modular dossier architecture

Job description

Sanofi is seeking a Launch Acceleration and Regulatory Enablement Lead to shape a new regulatory function. This role leads acceleration initiatives across Global Regulatory and R&D, defining end-to-end best practices and embedding acceleration principles early in development.

You will design training, drive modular content standardization, and partner with cross-functional teams to modernize submission workflows, applying AI and digital tools to improve speed and quality.