非公開
• Japan Regulatory Lead (JRL) is responsible for planning and execution of Japan regulatory strategy of the assigned products/projects by
- Providing strategic regulatory expertise for optimum market access of the products in Japan as a member of Japan project team and Global Regulatory Strategy Team (GRST)
- Leading communication of the global regulatory strategy and its implication to Japan so that the context of regulatory input are properly understood by the governance bodies in Oncology R&D (ORD) and BioPharma R&D (BRD) for their quality decisions through communication with GRST/Global regulatory execution team (GRET).
- Preparing, updating, and implementing regulatory operational plans to deliver regulatory outcomes of the assigned products/projects.
- Managing quality regulatory deliverables of the assigned products/projects throughout the product’s lifecycle.
• JRL works flexibly within and across the Therapeutic Areas to provide broad operational and/or strategic support to ensure regulatory deliverables
ワークライフバランスの良さや、社内(国内外)での豊富なキャリアパスが用意されている点が特徴のグローバル企業です。