Job Title: Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director)
Location : Cambridge, MA or 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 Global Regulatory Affairs (GRA) Device Head, Specialty Care Device and Combination Products will lead a team responsible for device regulatory activities associated with Sanofi’s combination product and medical device portfolio in the Specialty Care R&D and commercial product ranges. The team is comprised of direct reports and matrix team members. This position will provide input into the product strategy and to the direction provided to commercial and clinical teams. The incumbent will work closely with key stakeholders including clinical, medical affairs, R&D, Manufacturing & Supply (device development, manufacturing, quality, supply chain) and Global Business Units. Medical device technology is often exploring new territories that need “new” thinking and approaches from a regulatory perspective. This critical and highly visible position offers the successful candidate the opportunity to lead a team of colleagues working on combination product and medical device technologies, from pre-filled syringes, autoinjectors, pen injectors, nasal sprays, large volume injectors and other innovative combination product technologies, all of which are part of Sanofi’s exciting development pipeline. The GRA Device team is a globally diverse team supporting the medical device, combination product, biosurgery, 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. 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:
About You
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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 the refusal to submit to genetic testing) or any other characteristic protected by law.
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