GRA Device Lead, Associate Director

Job title: GRA Device Lead (Associate Director)

Location: Cambridge. MA, Morristown, NJ

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. 

The selected candidate will oversee key regulatory activities and report to the Global Regulatory Device Head for Digital Health and Diagnostics, who in turn reports to the Head of GRA Medical Devices.  The candidate will work in a matrix role, operating as an independent contributor on assigned projects and/or providing support on assigned projects with the diagnostics and/or combination product platform regulatory lead(s). 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 diagnostics 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. In-vitro diagnostics is often exploring new territories that need “new” thinking and approaches from a regulatory perspective.

This highly valuable position offers the successful candidate the opportunity to support a wide range of diagnostics, including diagnostics used in medicinal product clinical trials, diagnostic reagents and companion and complimentary diagnostics, 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 GRA-Devices lead on assigned project teams (early phase, late stage and marketed products), supporting diagnostics device aspects;

• Develop innovative and sustainable medical device regulatory strategies covering diagnostic (device elements);

• Prepare regulatory design control deliverables;

• Review design control deliverables;

• Lead and/or support global filing activities for diagnostics and diagnostics aspects of medicinal product submissions;

• Support device related health authority interactions;

• Provide regulatory impact assessments for proposed product 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

• 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 diagnostics and medical devices.

• 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

• Understanding of and experience with global regulatory requirements for in-vitro diagnostics and technical/industry standards related to clinical laboratory requirements;

• Basic understanding of regulations and guidelines related to drug development and registration is required;

• Proven ability to work cross-functionally in a highly professional global environment.

Skills/Qualifications

• M.S. degree –in a scientific or engineering discipline –with 6 years regulatory experience, or B.S. with 8 years regulatory experience. At least 3 years of relevant diagnostics regulatory experience required;

• At least 10 years in the global healthcare industry;

• Proven experience with in-vitro diagnostics regulatory strategies and approvals;