Job Details


・Develop and implement Japan regulatory strategy aligned with global regulatory strategy as much as possible.
・Responsible of leading health authority interactions and the preparation of regulatory submissions, which may include NDAs, Briefing Documents for various type of PMDA consultations, CTNs, Package Insert and Orphan Drug Applications, etc.
Serve as the primary interface to Global regulatory lead and JAPAC Reginal regulatory lead of each products.
・Management and Maintenance of business license activities
・Compliance review for documents and materials from regulatory perspectives
・Run a process of Package components’ artwork for Package Insert, Instruction for Use, Package Labels/Materials through the system


Knowledge and Skills:
・J-NDA filing and registration skills of medicines in Japan
・Comprehensive and deep knowledge for Pharmaceuticals and Medical Device Laws
・Expertise for regulatory compliance as post marketing regulatory activities
・Working in matrix environments in Japan and global teams as the One Team
・Communication skills
・English conversation, read, and writing
・IT skills: Microsoft Outlook/ Word/ Excel/Power Point
Education & Experience:
・Bachelor’s degree and at least 10 years of pharmaceutical industry experiences including at least 5 years in regulatory compliance activities such as business license management/maintenance and regulatory review for promotional and non-promotional materials





Job application

Apex delivers strong profile and highly skilled candidates that match the job description requirements. Their candidate know how, network and experience helped us to initiate contact and integrate the candidate into our company. We are very happy with the candidate selected by Apex. K.K. consulting service. Thank you for the professional recruitment consulting service throughout the selection and follow up. We really appreciated it and strongly recommend Apex.

APAC Head of Supply Chain

Global Healthcare Company