International Head, Global Regulatory Policy

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International Head, Global Regulatory Policy & Innovation

Job Description

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.
• Utilizes his / her experience to oversee the strategic assessment of external regulatory changes globally and, to work with subject matter experts within the Company, to drive or support the decision-making process to understand and prioritize the regulatory risks & opportunities globally: the internal impact analyses, development of strategies/ positions and drive for appropriate action(s) relevant to Takeda's Therapeutic Areas of focus and development projects.

ACCOUNTABILITIES:

Team / Pipeline Support (~45% of time). Provide strategic leadership to support regulatory and clinical teams in advancing our pipeline through:

• Internal Relationships + Team Engagement: Develop and maintain strong working relationships with GRA Head of International Regulatory Affairs, key management team, GRA internal stakeholders, and clinical teams.
• Product + Pipeline Strategy: Provide partnership to support product and pipeline strategy teams, including supporting PTRS Discussions and Engagement, developing precedent research and analysis, and developing external pre-competitive engagements relevant to product pipelines.
• Regulatory Agency Engagement: Utilize experience, industry contacts and external partners / consultants to facilitate and provide strategic guidance to internal regulatory and development teams regarding engaging and building reputation with regulatory agencies.
• Regulatory Intelligence and Education: Design and conduct regular processes, including internal briefings, to maintain internal awareness and understanding on external regulatory developments, and utilize experience to oversee the strategic assessment of external regulatory changes on internal pipeline.

External Engagement and Advocacy (~35% of time): Advance Takeda's external influence and reputation through external engagement around key regulatory policy opportunities through:

• Designing and Executing on External Advocacy Initiatives: With internal SMEs, identify key region-focused regulatory policy priorities directly relevant to internal pipeline development and build external advocacy strategy to target significant change.
• External Trade Association Management and Assessment: Coordinate and manage Takeda engagement within regional trade associations, including EFPIA and IFPMA, provide direction for regional Takeda SMEs, and communicate activities and intelligence to internal stakeholders.
• Engagement in External Forums and Workshops: Identify and negotiate external opportunities that bridge external policy priorities with internal product development, including IHI, ICH, IMDRF, and other similar forums. Support, coordinate and lead Takeda SMEs in engagement within external forums and workshops as appropriate.

Internal Initiatives + Support (20%)

• Regional Collaboration + Partnership: Work and support the global GRPI team to provide globally-focused and coordinated "one-voice" policy engagement.
• Internal Process Improvements + Automation: Identify opportunities to improve GRPI and GRAinformation management, tracking, metrics, and to simplify workflows through automation and the use of digital tools.
• Internal Community / Culture Engagement: Display leadership behaviors within Takeda to build the GRA Community and Culture.

SCOPE OF SUPERVISION:

Remotely Supervise 3 to 4 Direct Employees and Contractors.

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.
• Strong network with regulatory-focused trade associations, (e.g. EFPIA, IFPMA, TOPRA) and knowledge of Europe and Global regulatory agency structure and leadership.
• Strong communicator with foundational 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). Sound knowledge of intelligence tools and methods.
• Understands and interprets complex scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements, regulatory intelligence, policy and strategy for the region. Proven track record working with a major regulatory agency, specific experience in government affairs or policy is also desired.
• Excellent collaboration/relationship building, strong influencing and negotiation skills, integrity and adaptability. Outstanding written and oral communication skills as well as managing and adhering to timelines. Proven success at stakeholder engagement across organizational levels and boundaries.
• Must be strong overall and able to train/develop staff in the area of regulatory intelligence and policy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory trends and offers risk mitigation strategies.
• Ability to develop regulatory strategy to balance short and long term objectives, and support GRLs/regional regulatory leads to drive teams to make decisions and achieve deliverables within agreed parameters and timescales.
• Must be strong leader, working well with others, within global teams and communicating with senior leadership.
• Must be strong leader that creates vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way. Able to mentor and develop skills of staff.
• Experience in managing personnel required; experience managing relationships with CROs and/or contractors also preferred.

TRAVEL REQUIREMENTS:

• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
• Requires approximately 10-30%.

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