Associate Director, Japan Regulatory Affairs (RA) CMC, Plasma Derived Therapies (PDT)

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OBJECTIVES/PURPOSE

Act as a representative of Japan Regulatory Affairs CMC, PDT in a cross-functional team to proceed with development and lifecycle management for plasma-derived products.

• Responsible for regulatory CMC development, registration and post-approval strategies and plans for J-NDA of the assigned products throughout clinical development and commercial lifecycle. Ensures global strategies of the assigned products are successfully executed across both new product development and existing portfolio life cycle management.
• Successfully communicates and negotiates with Health Authorities as necessary, directly and indirectly to execute the strategy and plan for the assigned products.
• Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners.
• Demonstrates leadership and comprehensive understanding of RA CMC regulations and guidelines by applying interpersonal skills and expert RA CMC knowledge to address and overcome challenges that arise during development and commercialization.
• Develop people in Japan Regulatory Affairs CMC, PDT, and support resource planning and organizational management.

ACCOUNTABILITIES

• Have responsibility for the deliverables by performing the following roles expected for the assigned projects with minimal supervision:

• Plan and create CMC part of dossier throughout development, new drug application (NDA) and post-approval variation submissions according to agreed project timeline. (CTD M1.2, M2.3, queries and responses, partial change application (PCA), minor change notification (MCN), consultations, etc.).

• Pre-approval GMP compliance inspection and accreditation of sites for NDA and PCA.

• Periodic GMP compliance inspection and renewal of accreditation of foreign manufacturing sites.

• Collaborate and build relationships with counterparts in internal and external divisions/departments, regulatory authorities, etc. in order to fulfill the roles for above.

• Contribute to develop strategies and manage the organization of Japan Regulatory Affairs CMC, PDT, including appropriate personnel composition within the group and acquisition of knowledge and experience necessary to demonstrate high performance in the environment anticipated in the future, looking ahead the future direction of drug development, regulatory environment, etc.

• Talent development within the group and proposing human resources from inside and outside the company

• Support the Director for his/her management of budget and headcount of the group.

CORE ELEMENTS RELATED TO THIS ROLE

• Responsible for the success of Japan Regulatory Affairs CMC, PDT (A sense of responsibility and a strong will)

• Collaborate and build relationships with counterparts of internal global organizations, competitors in the same industry, and regulatory authorities (Requires high interpersonal negotiation skills).

• Contribute to strategizing and executing the organization's operations from a long-term perspective (Include strategies for utilizing internal and external resources) (Requires logical thinking and ability to take action)

• Contribute to managing group’s budget and headcount (Knowledge and experience of organization operation)

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Knowledge and experiences of CMC technology for pharmaceutical products (plasma-derived products, chemical synthesis, biologics, cell therapy, medical devices including software, etc.)

• Knowledge and experiences of GMP-related operations.

• Knowledge of regulations (Japan/Overseas), knowledge of regulatory trends

• Level of expertise is expected to be able to discuss contents of submission dossier (Module 3) of the assigned projects with SMEs (Subject Matter Experts) in internal/external organizations and regulatory authorities.

Leadership

• Set a good example to lead peers in Japan Regulatory Affairs CMC, PDT.

• Gain cooperation from relevant organizations (PS, GQS, GRA, etc.) [1-Level or 2-Level upper]

• Improve performance of peers in Japan Regulatory Affairs CMC, PDT by energizing members.

• Plan and execute talent development of peers in Japan Regulatory Affairs CMC, PDT.

Interaction

• Demonstrates the cooperation, collaboration, and involvement required for communication among people in charge (e.g. equivalent position), and draws the commitment of others through diverse communication. Build and influence internal and external relationships (e.g. escalation to 1-level upper).

• Coordinating ability to communicate ideas to, understand, and align interests with counterparts of relevant organizations.

• Perform a strategic approach to counterparts and stakeholders to get their cooperation based on mutual understandings.

Innovation

• Strategic thinking around potential impact on projects (including non-clinical and clinical), exceeding the scope of Japan RA CMC area.

• Contribute to plan and lead changes of Japan Regulatory Affairs CMC, PDT (organization structure, talents, outsourcing, etc.) to improve performance from the mid- to long-term perspectives.

Complexity

• High challenge complexity and impact (department/group level)

• Raise their own problems (Zero-base), develop hypotheses for resolution, and propose and implement solutions.

• Contribute to propose and execute changes considering future trend without basis of past examples or evidences.

• Learn and adopt new technology areas of the assigned projects within short period

Decision-making and Autonomy

• Determine and execute the direction/strategy of peers in Japan Regulatory Affairs CMC, PDT for which he/she is in charge, responses to regulatory authorities, and collaboration with Global.

• Support to determine assignment of projects, priority, delegation, resource allocation, budget, etc. within the group.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

• MSc preferred
• Executive knowledge of regulations and CMC technology of one or more types of products, such as plasma-derived products, biologics, small molecule, regenerative medicine, cell therapy products, etc.
• Knowledge of manufacturing and/or analytical testing of investigational/commercial products (experiences are preferred)
• Experiences of negotiation and communication with the Japanese regulatory agency (PMDA / MHLW).
• Good communication capability with various stakeholders in Japan and foreign countries
• People management experiences preferred
• Fluent English language skill is desired in oral and written commutation (e.g. TOEIC: greater than 750 points).

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.