【800～1300万円】CMCマネージャー

【求人No NJB2364696】
・Responsible for CMC related regulatory affairs activities to obtain regulatory approval for biosimilars in Japan.
・Activities such as the preparation publication of REG CMC documentation for submissions to Health Authorities （HA）.
・Interaction with HA on REG CMC questions to make new products and/or post marketed products successful.

（Major accountabilities）
・Lead CMC regulatory strategy with a focus on maximizing the business benefit balanced with regulatory compliance
・Lead submission activities （planning authoring reviewing coordination submission） for assigned projects/products.
・Experience and capabilities are required to personally perform new submission and post marketed products.
・Lead the submission by identifying required documents/ potential risks which could affect the defied timeline by assessing content and quality etc and by completing the application on time in line with a Global team・aligned project plan to obtain regulatory approval.
・Authoring and reviewing high quality RA CMC documentation for HA submission ensuring alignment with applying agreed CMC global regulatory strategies and current regulatory trends and guidelines.
・Prepare and communicate CMC Risk Management Assessments contingency plans and lessons learned on major submissions and escalate with management as appropriate.
・Initiate and lead HA interactions and negotiations as appropriate; setting objectives preparing/reviewing briefing books coordinating and planning rehearsals and risk mitigation plans.

（Work Experience）
・Operations Management and Execution
・Cross functional collaboration

（Skills）
・Preparation of RA CMC related documents for biosimilar marketing authorization applications
・Change Control
・Cross Functional Teams
・Documentation Management
・Negotiation Skills
・Project Management
・Regulatory Compliance
・Risk Assessment
・Risk Management

（Languages）
・English and Japanese