International Head, Global Regulatory Policy and

Vor 6 Tagen

Zurich, Schweiz Takeda Pharmaceutical Vollzeit

**International Head, Global Regulatory Policy & Innovation**

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as the International Head for Global Regulatory Policy & Innovation.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

As the International Head (Executive Director) for the Global Regulatory Policy & Innovation team, you will lead the Europe, Canada, and Growth / Emerging Markets (GEM) team efforts for regulatory policy, precompetitive collaborations, and advocacy issues. In this role, you will contribute to Takeda’s mission by building relationships with key regulatory decision makers globally. A typical day will include:
**OBJECTIVE**:

- Serve as International Head for regulatory policy and advocacy activities, and global regulatory intelligence lead for therapeutic areas and regional teams as determined in collaboration with regional US, Japan, China and Global Regulatory Research and Intelligence colleagues.
- Lead and develop company relationships with key regulatory agencies in Europe, ASEAN, LATAM regions with a focus on rare disease development, regenerative medicines, digital and data regulatory issues (incl. RWE), patient focused drug development, clinical development, and life-cycle management.
- Lead team of 3 to 4 FTEs globally regarding policy and advocacy activities and work collaboratively with US, Japan, and China colleagues to deliver a work plan to meet that vision. Work with Global Regulatory Policy and Innovation (GRPI) team to create global and regional vision for drug development and regulatory environment. Also works closely with the Regional Policy leads to drive success at the regional regulatory interface.
- With GRPI colleagues, define and oversee the systems/processes to monitor the regulatory environment for changes that may have an impact on Takeda’s products and goals. As such bring functional excellence to Global Regulatory Policy and Innovation. Drive best practices and excellence in execution within the department and cross-functionally.

**ACCOUNTABILITIES**:

- Lead Global Regulatory Policy & Innovation, GRA, and Takeda on EUCAN and 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 EUCAN and GEM regional trade associations and pre-competitive consortia to drive effective networking and representation to ensure a one voice policy.
- Lead the development and execution a regulatory intelligence strategy for EUCAN and GEM regions. 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.
- Oversee and have primary accountability/responsibility for the management and maintenance of special projects such as EUCAN and GEM Regulatory Affairs Priority Topic list, position papers, and regulatory issues/trends reports, as assigned.
- 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 globally to ensure coverage for regional responsibilities; Elevates needs when necessary.
- Responsible for demonstrating Takeda Leadership Behaviors.

**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**:

- BS - PhD, JD, MD, or equivalent strongly preferred.
- A minimum of 15 years pharmaceutical industry or regulatory agency experience. This is inclusive of 5 years regulatory experience or a combination of 10 years of regulatory and/or related experience in both development and post-marketing phases.
- Thorough Knowledge of regulations and guidance governing drugs and biologics in all phases of development, including post-marketing, in Europe and Global Markets, with a good understanding of basic regulatory requirements in other global markets (Japan, EU, US).

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