SUMMARY

The Device Regulatory Lead, Specialty Care and Vaccine In-Vitro Diagnostics is responsible for providing strategic and tactical support on Sanofi’s in-vitro diagnostics (IVD) portfolio, including use of IVDs in medicinal product clinical trials.  The individual serves as GRA-Devices lead or supports the GRA-Devices lead on assigned project teams (early phase, late stage and marketed products), supporting diagnostics device regulatory aspects. Reports directly to Global Regulatory Device Head for Specialty Care and Vaccine Digital and Diagnostics.

DUTIES

Diagnostics Regulatory Submissions

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

• Lead and/or support device related health authority interactions;

• 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

• Maintain regulatory databases for assigned projects

Diagnostics Project Support and Regulatory Strategies

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

• Prepare regulatory design control deliverables;

• Review and/or approve design control deliverables;

• 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;

• Engage with the relevant regulatory bodies and industry groups to influence industry standards and regulations, ensuring that Sanofi’s best interests are represented

Device Regulatory Processes

• Contribute to internal regulatory processes and procedures for diagnostics and medical devices

• M.S. degree –in a scientific or engineering discipline –with 5 years regulatory experience, or B.S. with 8 years regulatory experience. At least 3 years of relevant diagnostics and/or combination product regulatory experience;

• At least 8 years’ in the global healthcare industry;

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

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 the refusal to submit to genetic testing) or any other characteristic protected by law.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.