非公開
【概要】
The RA Manager will be responsible for ensuring first time approval of new products and new indications for existing products through participation in local brand teams.
【詳細】
・Develop local regulatory strategies and plan for major submissions to register New Chemical Entities (NCE) or new indications with Director of Regulatory Affairs and agree local submission timelines
・Lead the strategic discussion to accelerate development. Based on the strategy we developed, discuss with the regulatory authorities, and prepare for the early submission
・Ensure Japan submission requirements are communicated to relevant regional and global regulatory team
・Determine local Regulatory Risk for submissions and risk mitigation strategies where relevant
・Inform TA team manager of Regulatory Affairs and New Product Information (NPI) team of progress of applications and issues impacting local applications
・Lead major submissions to register NCEs or new indications for existing products when needed
・Lead new product labeling development to achieve the target product profile and post marketing appropriate use of the product. Maintain and revise current labeling timely and appropriately in accordance with Global Company Core Data Sheet comply with regulatory requirements including GVP.
・Maintain regulatory records for assigned product portfolio in compliance with local and global procedures
・Manage interactions with PMDA and MHLW and maintain a productive working relationship
・Participate in / coordinate special project assignments as determined by the Director of Regulatory Affairs
・Support to the commercialization of products through participation in local NPI brand teams
複数領域において豊富なパイプラインを持ち、今後ますます注目されていく外資系大手バイオ医薬品メーカー