Head, Global Regulatory Policy

**_ OBJECTIVES/PURPOSE _**

Summary:

- Reports to Head of Global Regulatory Policy and Innovation
- As a key member of Regulatory Policy & Innovation, this role involved working closely with Global Regulatory Policy and Innovation (GRPI) to create vision for Policy & Regulatory Innovation
- Develop and execute a regional Policy & Innovation strategy for the Growth & Emerging Markets (GEM), including APAC, LATAM, AMEA, and Eastern Eurasia.
- Key stakeholders including (but not limited to) GEM Regulatory Affairs, GEM BU including LOCs RA staff, GEM Medical Affairs, Market Access and Public Affairs groups

Objectives:

- GEM regulatory intelligence contact for key stakeholders
- Provide guidance for company relationships with other regulators and decision makers to further expand these relationships.
- In collaboration with GRPI, create the vision for regulatory policy priorities for the GEM regions and the delivery of a work plan to meet that vision.
- In collaboration with GRPI, define and oversee the standardization and implementation of systems/processes to monitor the regulatory environment for changes that may have an impact on Takeda’s products and goals. Bring functional excellence and drive best practices in executing functionally and cross-functionally.

**_ ACCOUNTABILITIES _**
- Represent Global Regulatory Policy & Innovation and GRA on GEM-focused internal and external forums/networks as assigned. Provides impactful summaries and strategic advice, back to the business, regarding assigned internal/external activities. Provides leadership to influence the regulatory environment to meet business needs.
- Oversee GRA and R&D participation in GEM regional committees to drive effective networking and representation to ensure a one voice policy.
- With GRPI colleagues, develop and execute an GEM regulatory intelligence strategy. Keep abreast of internal and external changes, trends, developments and other dynamics relevant to the regulatory environment that may have impact to Takeda’s regulatory and access strategies and propose action plan.
- Contribute and Lead, where appropriate, the development and implementation of appropriate systems, processes and standards within GRPI, GEM GRPI, GRA and across Takeda as assigned.
- Provide oversight for or have primary accountability/responsibility for the management and maintenance of special projects such as GEM Regulatory Affairs Priority Topic list, position papers, and regulatory issues/trends reports, as assigned.
- Partner with Government/Public Affairs to understand and monitor evolving trends for Access requirements regionally, work with internal stakeholders to identify opportunities/threats and advocate Takeda’s positions externally.
- Maintain consistent oversight of deliverables. Keep GRA management and all internal customers, partners and stakeholders abreast of progress and provide interim updates on ongoing activities and current initiatives. Ensure issues are escalated when needed and encourage resolution at the appropriate level.
- Lead routine and ad hoc meetings within function and cross-functionally. Presents to senior management as relevant.
- Leads personnel within GEM to ensure coverage for regional responsibilities; Elevates needs when necessary.
- Responsible for demonstrating Takeda Leadership Behaviors.

**_ DIMENSIONS AND ASPECTS _**

**Technical/Functional (Line) Expertise**
- Comprehensive understanding of the pharmaceutical industry

**Leadership**
- Demonstrated ability to work across functions, regions and cultures
- Functional level leadership with the ability to inspire, motivate and drive results
- Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
- Proven skills as an effective team player who can engender credibility and confidence within and outside the company
- Ability to distil complex issues and ideas down to simple comprehensible terms
- Demonstrates leadership presence and confidence
- Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
- Invests time in helping others to enhance their skills and perform at a higher level

**Decision-making and Autonomy**
- Decision making responsibilities:

- Provide input to highly complex decisions that impact the functional area
- Accountable for decision making for designated function
- Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
- Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution
- Accountable for providing input to and implementing vision and strategy for designated scope

**Interaction**
- Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
- Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the indus