非公開
・Leads the regulatory working team for Japan and represents as needed at project team and ensures regional regulatory lifecycle management strategy and submission planning written and executed according to plan – or oversees if delegated and/ or vendor.
・Partner with the Japan market access and to understand market access and reimbursement topics and support
opportunities to drive consolidated inputs into Japan product development plans.
・For the project(s)/product(s) of responsibility, collaborates with Global and Regional colleagues for the authoring of global regulatory strategies and ensures own critical deliverables as agreed within the global regulatory strategy and planning.
・Where responsibility includes a marketed product, provides oversight to ensure regulatory compliance, including oversight of the product related data in the registration database.
・Accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within Japanese responsibility.
・Identifies relevant Japanese regulatory requirements and provides regulatory guidance, and expertise to internal team on the assigned project(s) of responsibility. Authors and reviews Japan regulatory strategies as well as executes day-to-day activities for projects or may delegates to vendor with oversight.
・Usually includes supervision of vendor activities.
・Leads and manages meetings and / or interactions with regulatory authorities and agency meetings; or delegates and oversees direct reports and / or vendor; negotiates on behalf of project team as necessary.
・Regulatory reviewer in due diligence for licensing opportunities, development and /or marketed product opportunities.
・Proactively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc.) contacts/influence to achieve Takeda strategic goals and objectives.
・Identifies regulatory requirements and trends across area(s) of responsibility, and provides regulatory guidance, and expertise to Japan development team and/or higher governance bodies in these areas, as requested.
・Identifies and proposes solutions to the management of resource gaps for areas of responsibility.
・Presents to senior management as requested.
・Labeling management for TA products.
Develop labeling strategy and draft labeling for NDA/PCA submissions considering characteristics of the disease/compounds, trends in the industry, pricing/reimbursement system, PTRB etc.
Maintain JPI including revisions and its management, necessary regulatory procedures and coordination of relevant functions. etc.
・Product Information
Gather and Provide regulatory information for the existing products in response to queries from internal or external customers.
・Ad/Promo
Support Regulatory Review for promotional materials and publications.