RegulatoryManager

Job title: Regulatory Manager * _Location: Hatsudai, Tokyo_ __**About the job**__ **Role & Responsibilities** The incumbent regulatory professional is accountable for Japan strategic management of a portfolio of development projects and post-marketed products within Global regulatory CMC & Devices Japan. The incumbent is responsible for Japan regulatory CMC strategies, submission dossiers and approvals, including direct contact/liaison with PMDA/MHLW, for development phase of projects and for Change Controls. The incumbent creates collaborative working relationships with Global Regulatory CMC&D Focal Points (FP), Japan Regulatory Group, Technical and Quality Groups within R&D and Manufacturing and Supply (M&S), Regulatory Health Authorities, Others. The incumbent is also engaged in internal and external Regulatory Policy Organizations/Programs/industry association group in order to develop and maintain appropriate Sanofi representation in these activities. The incumbent demonstrates behaviors that live and promote the Sanofi and GRA Values/Principles/Competencies. 1\. Develops innovative Japan regulatory CMC strategies and risk assessments for development projects in collaboration with Global Regulatory CMC&D FP and/or other stakeholders. Assures that positive and collaborative relationships are developed with CMC teams to achieve the implementation of appropriate regulatory strategies. Assures that, for major CMC activities that have a critical regulatory and/or financial impact, appropriate strategies are developed to manage the activities, and risks are identified, communicated and mitigated as necessary. Contributute to the Global Regulatory CMC Strategy Document (GRSCD) to ensure that Japan regulatory requirement/target profile is adapted into the global CMC development. 2\. Assures that appropriate contacts with Health Authorities (PMDA/MHLW), in collaboration with Japan regulatory group , are initiated and addressed in an effective and timely manner, whilst d