Vice President, Regulatory Affairs Japan

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Job Description

OBJECTIVES/PURPOSE

• As a member of the Global Regulatory Affairs leadership team, contributes to the vision and goals of Global Regulatory Affairs (GRA) and ensures that Global Regulatory Affairs (GRA-J) Japan objectives are aligned with those.
• As a member of Takeda Development Center Japan (TDC-J) leadership team, creates the environment that enables TDC-J members to drive clinical programs and other initiatives in TDC-J.
• Collaborates and aligns with GRA as appropriate and acts as the GRA Japan entire representative where the incumbent is located.
• Provides leadership, strategic direction, and managerial oversight to GRA Japan team to develop and execute regulatory strategies and plans for Japan region.
• Work as a leadership position among regulatory related functions in Japan to support them in engagement, career development, and talent management.

ACCOUNTABILITIES

• Develop organizational vision and goals and build an organization accordingly by acquiring necessity talents and capabilities.
• Provide mindsets and expertise based on vision, value, Takeda-ism in RA Japan to ensure that emerging trends/issues are addressed by utilizing creative problem-solving skills, and proactively influencing GRA.
• Drive business with GRA LT and TDC-J LT to realize vision, strategies, and goals in GRA, TDC-J as well as Takeda.
• Manage and supervise regulatory activities in Japan including development of processes to ensure efficient and timely registration of development products and maintenance of marketed ones. Ensure regulatory submissions with high quality and timely manners.
• Ensure full compliance with government regulations and corporate policies by promoting compliance policies.
• Develop and maintain comprehensive and strong partnering relationships with health authorities in Japan as well as internal division heads.
• Support RA Japan members in negotiating with regulatory authorities to achieve positive outcomes to Takeda.
• Ensure that key regulatory requirements and commitments in Japan are brought to the attention of senior managements, such as GRA head, TDC-J head etc.
• Elevate the capabilities of the organization and talent in GRA Japan from the mid- to long-term perspective, e.g., through talent development and securing human resources from inside and outside the company.
• Make the most of resources (budget and headcount) in GRA Japan to achieve the vision and goals.

CORE ELEMENTS RELATED TO THIS ROLE

• Responsible for Global Regulatory Affairs Japan as a whole (A sense of responsibility and a strong will)
• Collaborate and build relationships with executives of internal global organizations, high level RA managements in other pharmaceutical companies, and directors in regulatory authorities (Requires high interpersonal negotiation skills)
• Strategizing and executing the organization's management from a long-term perspective (Include strategies for utilizing internal and external resources) (Requires logical thinking and ability to act)
• Manage budget and headcount in GRA Japan (Knowledge and experience of organization operation)
• Consider the future of GRA Japan organization (including vision, goal etc.) and practice to achieve it.
• Introduce new initiatives to activate GRA Japan organization in collaboration with internal and external stakeholders.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise(Breadth and depth of knowledge, application and complexity of technical knowledge)

• Basic scientific knowledge of the Takeda therapeutic area
• Knowledge of regulations (Japan/US/EU), knowledge of regulatory trends
• Business understanding in Takeda (Direction, trend, etc. of the company)
• Experience in Regulatory and drug development

Leadership(Vision, strategy and business alignment, people management, communication, influencing others, managing change)

• Manage activities of GRA Japan including resources, budgets, regulatory information management system, and planning in line with GRA activities.
• Drive performances in GRA Japan to set clear expectations and goals, to provide supports to manage the performance of direct reports, to coach individual members to ensure their contribution as needed, to evaluate performance following feedback and recognitions.
• Build a productive team by hiring a highly qualified persons in partnering with HR, by building engaging culture, by clarifying roles and responsibilities as well as goals.

Interaction(The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)

• Demonstrates the collaboration, and engagement required for communication among persons in charge, and draws the commitment of others through diverse communication. Build and influence internal and external relationships including management levels in regulatory authorities.
• Coordinating ability to communicate ideas to, understand, and align interests with GRA and TDC-J managements.

Innovation(The required level of scientific knowledge, knowledge sharing, innovation and risk taking)

• Expands the scope of external organizations (Government, industry organizations, and other companies) and approaches them, and proposes and executes improvements that will change systems and processes.
• Strategy planning in GRA, as well as TDC-J
• Plans and leads changes of the entire department from the mid- to long-term perspectives.

Complexity(Products managed, mix of businesses, internal and/or external business environment, cultural considerations)

• High challenge complexity and impact (Divisional/organizational level)
• Raises their own problems (Zero-base), develop hypotheses for resolution, and propose and implement solutions.
• Solves a problem with more experiences and resolution options than Role 4.
• Finds common ground between stakeholders for any unresolved issues and resolves them.

Decision-making and Autonomy(The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)

• Determines and executes the direction/strategy in development products and regulatory matters in RA Japan in collaboration with global.
• Allocation of appropriate resources and budgets

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• A degree in MSc (mandate), or Ph.D. (preferred) in life science area, such as Biological, Medical Science, Pharmacy etc.
• At least 10 years experiences in Regulatory Affairs, supported by additional pharmaceutical / industry experiences.
• Extensive experiences in a senior level in Regulatory Affairs, Quality, or other relevant legislation and processes (PMDA, FDA, EMA).
• General Management experiences with line management and leadership at senior management level.
• Demonstrable experiences of effective delivery of objectives in complex matrix environments.
• Negotiation and communication skills with high-level management in regulatory authorities.
• Communication skills beyond cultures.

Takeda Compensation and Benefits Summary:

• Allowances: Commutation, Housing, Overtime Work etc.

• Salary Increase: Annually, Bonus Payment: Twice a year

• Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45

• Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)

• Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.

• Flexible Work Styles: Flextime, Telework

• Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.

Important Notice concerning working conditions:

• It is possible the job scope may change at the company’s discretion.

• It is possible the department and workplace may change at the company’s discretion.

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