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About the Role
Our Diagnostics Business Group is challenging the creation of new medical value utilizing digital and biomarkers from a diagnostic perspective. We are looking for a regulatory affairs professional to lead the new development of medical devices and in vitro diagnostic reagents.
Responsibilities
- Lead domestic and international regulatory procedures.
- Involve R&D, Quality, and Marketing to formulate strategies, prioritize, and drive decision-making towards approval.
- Plan and lead manufacturing and sales approval applications (new, changes, renewals) domestically and internationally.
- Negotiate with regulatory authorities (respond to inquiries, organize discussion points, negotiate and reach agreements).
- Formulate policies for insurance application, coordinate internally, and handle authority correspondence.
- Support QMS-related tasks, considering audits and conformity assessments from the development stage.
Requirements
- Experience in manufacturing and sales approval applications for pharmaceuticals, medical devices, or in vitro diagnostic reagents (5+ years).
- Experience in formulating application and regulatory authority response strategies and driving them cross-departmentally.
- Experience in external negotiations.
Skills
- CMC knowledge
Location
- Tokyo
Work Type
- Full-time
Experience Level
- 5+ years
Salary/Compensations
- Based on our company's regulations
Benefits
- Health insurance
- Welfare pension
- Unemployment insurance
- Commuting allowance
- Housing allowance
About the Company
- Our Diagnostics Business Group is challenging the creation of new medical value utilizing digital and biomarkers from a diagnostic perspective.