GRA Device Lead (Director)

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing : a desire to make miracles happen. So, let's be those people.

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US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; colour; ancestry; religion; national origin; age; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

North America Applicants Only

The salary range for this position is : $172,500.00 - $249,166.66. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

Job Title : GRA Device Lead

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 GRA Device team is a globally diverse team supporting the medical device, combination product, digital health and in-vitro diagnostic products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research and Development.

Sanofi's global regulatory affairs (GRA) function is comprised of more than 1800 people. The GRA Device Lead for Specialty Care Combination Products will oversee key regulatory activities and report to the GRA Device Team Leader for Specialty Care Combination Products, who in turn reports to the Head of GRA Device. The candidate will work within a matrix environment, operating as a strong independent contributor on assigned projects. The role will represent the GRA Device perspective as a member of project specific cross functional global regulatory team (GRT) and is accountable to develop and maintain device aspects of project regulatory strategy documents.

The incumbent will provide strategic and tactical support on Sanofi's combination product portfolio and will also have the opportunity to work on other innovative projects. The incumbent will work closely with key stakeholders including clinical, medical affairs, Industrial Affairs (Device Development, manufacturing, quality, supply chain) and drug product development. Combination product and drug delivery device systems technology is often exploring new territories that need "new" thinking and approaches from a regulatory perspective. The incumbent will be expected to proactively initiate discussions with regulatory authorities and contribute to industry standards and guidelines. The incumbent has a patient- and quality-focused mindset and drives a culture of continuous improvement in compliance with Sanofi's behavioral and ethical standards.

This critical and highly visible position offers the successful candidate the opportunity to support a wide range of combination products, from pre-filled syringes, autoinjectors, pumps and other innovative combination product technologies, all of which are part of Sanofi's exciting development pipeline.

We are an innovative global healthcare company with one purpose : to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities :

• Serve as Device Regulatory Lead on assigned project teams (early phase, late stage and marketed products).
• Develop innovative and sustainable medical device regulatory strategies covering combination products and delivery systems (device elements).
• Provide regulatory guidance and advice to development teams.
• Prepare regulatory design control deliverables.
• Review and approve design control deliverables.
• Lead and / or support global filing and lifecycle management activities for device aspects of combination product submissions.
• Contribute to product development planning, including strategies to bridge delivery systems during development and post-approval changes.
• Identify and manage issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and / or escalation as needed.
• Ensure regulatory plans are monitored, progress / variance communicated to Management and any risks are highlighted.
• Lead and / or support device related health authority interactions.
• Provide regulatory impact assessments for proposed product changes.
• Work closely with internal and external partners to ensure regulatory risks are identified, communicated, and properly addressed.
• Contribute to internal regulatory processes and procedures for medical devices and combination products.
• Engage with the relevant regulatory bodies and industry groups to influence industry standards and regulations, ensuring that Sanofi's best interests are represented.

About You

Knowledge :

Skills / Qualifications :

Why Choose Us?

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including