GRA Device Lead (Associate Director)

Job Title: GRA Device Lead (Associate Director)

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

About the Job

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 the Sanofi portfolio of products.  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 is accountable for developing and implementing 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.  The team creates and maintains strong collaborative working relationships 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 Specialty Care Device and Combination Products 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. Ready to get started?

The GRA Device Lead role is a critical and highly visible position offers the opportunity to support a wide range of combination products, from prefilled syringes, pen injectors, autoinjectors, large volume devices and other innovative technologies. Working at the intersection of science and compliance, you'll develop device strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities. You'll collaborate across R&D, Device, Manufacturing, and Quality teams while preparing high-quality regulatory submissions, managing compliance, and anticipating regulatory trends—all contributing directly to bringing innovative therapies to patients worldwide.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world and are supported and enhanced through our diverse portfolio of medical device and diagnostic products. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities

• Liaises with device, clinical, manufacturing, commercial, and other internal business partners to enable successful regulatory outcomes 

About You

This position requires an experienced regulatory affairs professional with familiarity with international submissions from within a global healthcare organization.  You will have had experience in large organizations given the need to be able to interact across the Sanofi organization.

• Experience: 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 5+ years of relevant medical device and/or combination product regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions.

• Regulatory Expertise: Experience preparing regulatory documentation and familiarity with standard submission processes.

• Technical Knowledge: Understanding of clinical development of medicinal products,