GRA Device Lead (Associate Director) - all genders

About the job

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

• 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 combination products and delivery systems (device elements)
• Define device Health Authority interactions plan, lead device related health authority interactions and support cross-functional health authority interactions
• Identifies medical device regulatory acceleration opportunities and regulatory risks, and proposes thoughtful risk mitigations in collaboration with the GRT
• Identify and manage issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed
• Lead global filing and lifecycle management activities for device submissions/device aspects of medicinal product submissions
• Liaises 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
• Participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to device regulations
• Contributes to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate device committees, forums
• Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, communication and document management
• Contribute to internal regulatory processes and procedures for MD/IVD
• Accountable for regulatory assessment for MD/IVD Due Diligence activities as applicable

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, device development (including design controls), manufacturing processes, and regulatory requirements in major markets.  Working knowledge with technical/industry standards related to injection devices.  Ability to synthesize and critically analyze data from multiple sources.
• Collaboration Skills: Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Device, Manufacturing, and Quality teams.  Demonstrates business acumen, strong leadership, influencing and persuasive negotiation skills.
• Soft Skills: Demonstrate strategic thinking, initiative, change agent leadership and risk assessment proficiency, including ability to integrate overall business objectives into actionable project strategies.
• Education: Bachelor's degree in a scientific or engineering discipline.  Graduate degree preferred.
• Communication: Strong written and verbal communication and influencing skills, with fluency in English.
• Adaptability: Capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site), with openness to learning and growth.

Why choose us?

• Play a crucial role in bringing innovative therapies to millions worldwide, working at the forefront of drug discovery and development with a patient-centric approach.
• Leverage advanced AI, data, and digital platforms to push the boundaries of pharmaceutical science and regulatory strategy.
• Engage with diverse teams spanning scientific, clinical, and digital fields, fostering breakthroughs through cross-functional collaboration.
• Benefit from structured career paths offering both scientific and leadership advancement opportunities, including bold moves and short-term projects to expand your expertise.
• Join a workplace that prioritizes diversity, equity, and inclusion, with programs that celebrate every voice and perspective.
• Enjoy a supportive R&D environment that values work-life balance, offering flexible working options (60% on-site) and comprehensive well-being programs.
• Influence global regulatory strategies, interact with key health authorities, and stay at the forefront of evolving industry trends and regulations.

PursueProgress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.  Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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