Manager, Regulatory Policy & Innovation Japan

​OBJECTIVES/PURPOSE

1. From regulatory intelligence and policy stand point, leads team activities related to followings and advises team members as needed.
2. Defines, develops and leads Japan regional regulatory strategies to enable patient access to meaningful medicines in alignment with program objectives.
3. Effectively communicates objective assessments of the likelihood of success of these regulatory strategies. Provides strategic and tactical advice and guidance to TA-RA and Japan development teams to achieve timely and efficient conduct of development programs and/or oversight of marketed product support, while maintaining full compliance with applicable regulatory requirements.
4. Provides regulatory expertise for multiple projects, focused on non-clinical and clinical aspects of drug development and / or post-marketing compliance and life cycle management in assigned therapeutic areas. 
5. Provides leadership and development for multiple team members for the design and execution of regional and / or Japan regulatory strategies in collaboration with TA-RA and other stakeholders

ACCOUNTABILITIES

1. Has ultimate responsibility for the deliverables by appropriately assigning them to perform the following roles expected for assigned project teams and tasks:
2. Based on the GRIP and Regional RA strategies, appropriately allocates resources within the group to demonstrate performance in the environment expected in the future, with an eye on the future direction of drug development, regulatory environment, etc. 
3. Contribution to issue resolutions for both development and marketed products through communication and negotiation with health authorities.
4. Collecting information through various channels including industry and authorities and feedback them to the company internal stakeholders.
5. Keeping high reputation of the company by attending industry groups.
6. Sharing of Regulatory Intelligence and building and implementing policies as a member of GRIP.
7. Builds relationship and cooperates with inhouse group managers and counterparts, people in the authority, reviewers, auditors, etc.

CORE ELEMENTS RELATED TO THIS ROLE

1. Responsible for Regulatory Intelligence and Policy group for assigned projects (A sense of responsibility and a strong will)
2. Collaborates and builds relationships with executives of internal global organizations, members of industry associations from other companies, and regulatory authorities at the level of managers   and reviewers(Requires high interpersonal negotiation skills)
3. Strategizing and executing the organization's operations (Include strategies for utilizing internal and external resources) (Requires logical thinking and ability to take action)

1. Knowledge of the therapeutic areas in Takeda.
2. Knowledge of regulations (Japan/Overseas), knowledge of regulatory trends
3. TAU, GPT (Commercial, MA, GMS), and other relevant functional area business understanding
4. Experience in Regulatory area or related functions (clinical development etc.)
5. Leadership
6. Leads projects based on the vision/strategies  of the group teams
7. Develops staff members of the assigned project team to obtain basic understanding of regulations
8. Coordinates with other divisions in his/her area
9. Interaction
10. Demonstrates the collaboration required for communication among persons in charge, and draws the commitment of others through diverse communication. Builds and influences internal and external relationships.
11. Coordinating ability to communicate ideas, understand, and align interests with regulatory agencies
12. Innovation
13. 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.
14. Strategy planning across projects
15. Complexity
16. Raises their own problems (Zero-base), develops hypotheses for resolution, and proposes and implements solutions under support/advice from Director or Associate Director.
17. Solves a problem with more experiences and resolution options than Role 1
18. Decision-making and Autonomy
19. Determines and executes the direction/strategy in assigned projects in which he/she is in charge, responses to regulatory authorities, and collaboration with global.
20. MSc preferred
21. Basic knowledge of regulations and medical in Takeda core TA