Associate Director, Japan Regulatory Affairs (RA) CMC, Plasma Derived Therapies (PDT)
Takeda · JP
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About the Role
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.
Responsibilities
- Plan and create CMC part of dossier throughout development, new drug application (NDA) and post-approval variation submissions.
- Oversee pre-approval GMP compliance inspection and accreditation of sites for NDA and PCA.
- Manage periodic GMP compliance inspection and renewal of accreditation of foreign manufacturing sites.
- Collaborate with internal and external divisions/departments, and regulatory authorities.
- Contribute to developing strategies and managing the organization of Japan Regulatory Affairs CMC, PDT.
- Support talent development within the group and propose human resources.
- Support the Director in managing the group's budget and headcount.
Requirements
- Demonstrates leadership and comprehensive understanding of RA CMC regulations and guidelines.
- Ability to apply interpersonal skills and expert RA CMC knowledge to address and overcome challenges.
- Executive knowledge of regulations and CMC technology for one or more product types (plasma-derived, biologics, small molecule, regenerative medicine, cell therapy).
- Knowledge of manufacturing and/or analytical testing of investigational/commercial products.
- Experience negotiating and communicating with the Japanese regulatory agency (PMDA / MHLW).
- Good communication capability with various stakeholders in Japan and foreign countries.
- People management experience preferred.
- Fluent English language skill is desired (e.g., TOEIC > 750).
Skills
- Regulatory CMC development
- Registration and post-approval strategies
- Health Authority communication and negotiation
- Interpersonal skills
- RA CMC regulations and guidelines
- CMC technology for pharmaceutical products
- GMP-related operations
- Regulatory trends
- Leadership
- Talent development
- Organizational management
- Budget management
- Headcount management
- Negotiation skills
- Logical thinking
- Ability to take action
- Strategic thinking
- Coordinating ability
- Communication
Location
- Osaka, Japan
- Tokyo, Japan
Work Type
- Employee
- Regular
- Full time
- Flextime
- Telework
Experience Level
- Minimal supervision required for project deliverables.
Education Level
- MSc preferred
Salary/Compensations
- Salary Increase: Annually
- Bonus Payment: Twice a year
Benefits
- Commutation allowance
- Housing allowance
- Overtime Work allowance
- Social Insurance
- Retirement and Corporate Pension
- Employee Stock Ownership Program
About the Company
- Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company.
- Committed to improving the lives of patients worldwide by striving towards breakthroughs in life-changing medicines.