Head of Global Regulatory Policy

Job Description

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us the Head of Global Regulatory Policy in Washington, D.C.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Head working on the Global Regulatory Policy team, you will set Takeda’s overall Global Regulatory Policy roadmap, actively shaping and influencing global policy impacting Takeda development in the regulatory environment including laws, regulations, and guidance’s, and a typical day will include:

OBJECTIVES/PURPOSE

• Leads Takeda activities in Trade Association initiatives, Health Authority policy-focused meetings, and public-private initiatives to shape regulatory policy in alignment with Takeda R&D agenda.
• Partners with global and regional subject matter experts and groups to lead direct regulatory advocacy and influencing activities relating to regulatory policies, including digital R&D policies.
• Providing strategic input and tactical support to TET level leadership, TAUs and GPTs, with the goal of empowering informed decision-making to bring products to market and maintain their availability for patients.
• Develops and implements and drives effective approaches to US/EU/Japan/GEM regulatory policy activities, including generating positions, advocacy plans, stakeholder analysis, tracking, and internally communicating.
• Accountable for shaping Global Regulatory guidance and expertise to TET level governance bodies, and teams across R&D, GMS and BUs based on identification of regulatory requirements and trends
• Leads Takeda input to Trade Association initiatives, FDA/EMA/PMDA/GEM meetings, and consultations including those related to digital health.

ACCOUNTABILITIES

• Serves as a member of the GRA Leadership Team, influencing the operations and future strategy of the department.
• Leads team of Global regulatory policy experts and/or cross-functional teams responsible for proactively monitoring, responding and shaping emerging scientific trends/strategies (internal and external).
• Leads Takeda interactions with FDA/EMA/PMDA/GEM on advocacy issues, enhancing and fostering relationships with key decision makers in policy and legislative areas, and leverage regulatory policy to gain insight and intelligence in the US.
• Identify, define and implement global advocacy priorities and strategies, working with colleagues across Takeda, GPTs, Government Affairs, and Legal.
• Accountable for providing Regulatory guidance and expertise to TET level governance entities, and teams across R&D, GMS and BUs based on identification of regulatory requirements and trends.
• Leads Takeda input to Trade Association initiatives, FDA/EMA/PMDA/GEM meetings, and consultations including those related to digital health.
• Drives global regulatory commenting efforts and facilitates the input of Takeda expert information to help shape and influence key regulatory policies.
• As the subject matter expert, advises Takeda personnel on current regulatory guidelines and procedures as well as emerging regulatory/legislative issues that impact Takeda businesses or products.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Comprehensive understanding of the pharmaceutical industry and Regulatory Affairs
• Global regulatory policy expertise with demonstrated strong ability for collaboration and team leadership; experience leading and working with cross-cultural teams.
• Experience in supporting Value Based Healthcare

Leadership

• Demonstrated ability to work across functions, regions and cultures
• Enterprise 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
• Executive leadership presence and confidence
• Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
• Ability to develop and drive a Global Workforce and Talent strategy for colleagues in the Global, Regional and Local organizations

Decision-making and Autonomy

• Broad decision-making responsibilities:
  • Ability to make highly complex decisions that impact the enterprise
  • Accountable for decision making for Global Regulatory Policy function
  • Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
  • Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution
• Accountable for designing and implementing vision and strategy for designated scope

Interaction

• Effectively navigates the changing external environment and leads others through change by creating and inspiring and engaging workplace
• Ability to effectively implement R&D’s global policy roadmap
• Effectively represent Takeda in High-level negotiations with the ability to resolve conflict in a constructive manner
• Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions, including but not limited to TAs, BUs, GPSE, LOC, Market Access, GOR

Innovation

• Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation
• Comfortable challenging the status quo and bringing forward innovative solutions
• Ability to take risks implementing innovative solutions, accelerating time to market

Complexity

• Ability to work in a global ecosystem (internal and external) with a high degree of complexity
• Breadth of knowledge required across therapeutic areas, indications, and/or modalities
• Experience operating in a multi-disciplinary drug development environment including international experience and exposure to a variety of therapeutic areas.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Minimum BS degree; advanced degree (MS, MBA, PhD or JD) preferred with 20 years of experience in regulatory policy or health policy
• Extensive experience in interacting/negotiating with US, EU and global agencies
• Senior management experience in regulatory policy, with a demonstrable history of regulatory success over multiple years driven by a strong understanding of the regulatory and legislative environment is required
• Proven track record demonstrating an ability to analyze new regulations or policies and assess the impact on the pharmaceutical business or development programs is required
• Organizational awareness (e.g., interrelationship of departments, business priorities), is required with significant direct exposure to senior management
• Proven track record of leading and driving business process transformation as well as delivering on programs with complex business deliverables
• Health care business acumen with a comprehensive understanding of the pharmaceutical industry

Location and Salary Information:

• This job posting excludes CO applicants

WHAT TAKEDA CAN OFFER YOU:

• 401(k) with company match and Annual Retirement Contribution Plan
• Tuition reimbursement
• Company match of charitable contributions
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

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