International Head, Global Regulatory Policy & Innovation

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Join Takeda as the International Head (Executive Director) for the Global Regulatory Policy & Innovation where you will lead the Europe, Canada, and Growth / Emerging Markets (GEM) team efforts for regulatory policy, precompetitive collaborations, and advocacy issues. You will contribute to Takeda’s mission by building relationships with main regulatory decision makers globally

• ·         Lead and develop company relationships with main 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 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 work with the Regional Policy leads to achieve 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. Promote best practices and excellence in execution within the department and cross-functionally.

  ·         Uses your experience to oversee the strategic assessment of external regulatory changes globally and, to work with subject matter experts within the Company, to support the decision-making process to prioritize the regulatory risks & opportunities globally:  the internal impact analyses, development of strategies/ positions and achieve 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 strong working relationships with GRA Head of International Regulatory Affairs, main management team, GRA team members, 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: Use 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 use 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 main regulatory policy opportunities through:

  •      Designing and Implementing External Advocacy Programs: With internal SMEs, identify key region-focused regulatory policy priorities directly relevant to internal pipeline development and build external advocacy strategy to target change.

  •      External Trade Association Management and Assessment: 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 lead Takeda SMEs in engagement within external forums and workshops. 

  Internal Programs + 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 Management:

  Remotely Manage 3 to 4 Direct Employees and Contractors.

• EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  ·         BS – PhD, JD, MD, or equivalent.

  ·         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.

  ·         Network with regulatory-focused trade associations, (e.g. EFPIA, IFPMA, TOPRA) and knowledge of Europe and Global regulatory agency structure and leadership.

  ·         With knowledge of regulations and guidance governing drugs and biologics in all phases of development, including post-marketing, in Europe and Global Markets, with an 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. Track record working with a major regulatory agency, specific experience in government affairs or policy is als desired

  ·         Excellent collaboration, influencing and negotiation skills, integrity and adaptability. Outstanding written and oral communication skills and managing and adhering to timelines. Experience 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; identify 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.

  ·         A strong leader, working well with others, within global teams and communicating with senior leadership and who creates vision for group.  Inspire and motivate group.  Take stand on important issues in productive, respectful way. Mentor and develop skills of staff.

  ·         Experience managing personnel required; experience managing relationships with CROs and 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%.

  Empowering Our People to Shine

  Learn more at takedajobs.com.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.