CMC Regulatory Manager

Job title: CMC Regulatory Manager

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 ...