Global Regulatory Affairs Device Lead; Associate Director

Global Regulatory Affairs Device Lead (Associate Director)

Apply for the Global Regulatory Affairs Device Lead (Associate Director) role at Sanofi.

Location: Morristown, NJ or Cambridge, MA or Framingham, MA

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the medical device, combination product, digital health, and in‑vitro diagnostic (IVD) products within Sanofi’s portfolio.

The team is part of the GRA CMC & GRA Device Department within Global R&D. The GRA Device organization serves as a critical strategic partner within Sanofi’s regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. Our department bridges the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways.

The team develops and implements global regulatory strategies for device and IVD products, intended to be used alone or in combination with a drug product, leading regulatory efforts in the development and post‑marketing stages. It collaborates with Global Regulatory Affairs (GRA), Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Manufacturing & Supply, Regulatory Health Authorities, and others.

As GRA Device Lead in the GRA Device, General Medicine and Vaccine Medical Device and Combination Product team you’ll drive global regulatory strategies for medical device and combination products, collaborate with cross‑functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and directly influence the success of product approvals through strategic negotiations with health authorities worldwide.

• Serve as GRA Device Lead on assigned project teams (early phase, late stage and marketed products)
• Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross‑functional teams
• Develop and execute innovative and sustainable medical device regulatory strategies covering stand‑alone medical devices and device parts of combination products
• Define device Health Authority interactions plan, lead device‑related health authority interactions and support cross‑functional health authority interactions
• Identify medical device regulatory acceleration opportunities and regulatory risks, and propose thoughtful risk mitigations in collaboration with the GRT
• Identify and manage issues and opportunities that impact submission timelines; ensure appropriate communication, resolution and/or escalation as needed
• Lead global filing and lifecycle management activities for device submissions / device aspects of medicinal product submissions
• Liaise with device, clinical, manufacturing, commercial, and other internal business partners to enable successful regulatory outcomes
• Prepare, review and approve design control deliverables
• Contribute to product development and lifecycle management planning
• Provide regulatory impact assessments for proposed product changes
• May serve as a regional/local regulatory lead and point of contact with medical device Health Authorities for projects/products in their remit, as needed
• Participate in the development and monitoring of the global regulatory environment and updating of standards and processes related to device regulations
• Contribute to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate device committees, forums
• Support operational and compliance activities for assigned deliverables, develop, execute regulatory submission planning activities, including generating submission content plans, submission tracking, communication and document management
• Contribute to internal regulatory processes and procedures for medical devices
• Accountable for regulatory assessment for medical devices Due Diligence activities as applicable