Compliance

• Anticipate, assess, and influence US regulatory policy impacting innovative drug development
• Create and amplify relationship-building opportunities with U.S. regulators and key external stakeholders in the regulatory policy landscape
• Provide strategic, directional, and tactical guidance to product teams and business units
• Support the development of strategies and positions, and drive appropriate actions aligned with Takeda’s therapeutic areas and development projects
• Serve as US expert and subject matter lead for regulatory policy and advocacy activities
• Collaborate with GRPI team to create global and regional vision for drug development and regulatory environment
• Develop and maintain strong working relationships with GRA LT, GRA Heads of Therapeutic Area Units, Regulatory Affairs Leads, and GPT leaders
• Provide partnership to support product and pipeline strategy teams
• Utilize experience, industry contacts and external partners to provide strategic guidance regarding engaging and building reputation with regulatory agencies
• Maintain internal awareness and understanding of external regulatory developments
• Identify key region-focused regulatory policy priorities and build external advocacy strategy to target significant change
• Coordinate and manage Takeda engagement within trade association, provide direction for Takeda SMEs, and communicate activities to internal stakeholders
• Identify and negotiate external opportunities that bridge external policy priorities with internal product development
• Support Global Head, GRPI in staffing senior executives on external Boards and Committees
• Work with global GRPI team to provide coordinated “one-voice” policy engagement
• Identify opportunities to improve GRPI and GRA information management, tracking, metrics, and simplify workflows through automation and digital tools.
• Display leadership behaviors within Takeda to build the GRA Community and Culture.

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