Global Regulatory Affairs, CMC Lead, Vaccines
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About The Position
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 Chemistry, Manufacturing and Controls (CMC) regulatory team is accountable for the global regulatory strategy for development and marketed products within GRA. The team responsibilities include but are not limited to: global regulatory CMC strategies, submission dossiers and approvals, direct contact/liaison with FDA/EMA for new and marketed chemical entities. 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 Industrial Affairs, Regulatory Health Authorities, and others. The team demonstrates behaviours that live and promote the Sanofi Play to Win behaviours and GRA Values/Principles/Competencies. 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?
