Not specified (assumed hybrid or onsite based on location).
Japanese regulatory strategy leadership
Ctd preparation and submission
Health authority negotiation and response
Johnson & Johnson is seeking a Regulatory Strategy & Liaison Specialist/Manager for their Innovative Medicine division in Tokyo, Japan. The role involves leading regulatory strategies, managing submissions, and collaborating with global teams to ensure compliance and successful product development in the Japanese market
Job Summary
Johnson & Johnson empowers healthcare innovation to prevent, treat, and cure complex diseases with smarter and less invasive treatments.
The role leads Japanese regulatory strategy, manages CTD preparation for J-NDA submissions, and negotiates with Japanese health authorities.
The position involves close collaboration with global regulatory teams and supports regulatory activities for product registration and lifecycle management.
Matching Summary
Match Score: 85
Johnson & Johnson is seeking a Regulatory Strategy & Liaison Specialist/Manager for their Innovative Medicine division in Tokyo, Japan. The role involves leading regulatory strategies, managing submissions, and collaborating with global teams to ensure compliance and successful product development in the Japanese market.
Skills & Requirements
Must-have
Japanese regulatory strategy leadership
CTD preparation and submission
Health Authority negotiation and response
Japanese labeling strategy development
Cross-functional team collaboration
Regulatory strategy input for clinical studies
Nice-to-have
Proactive team player
Ability to adapt to changing regulatory environment
Strong communication in Japanese and English
Experience with global regulatory teams
Flexibility for international meetings
Key Requirements
Bachelor’s degree or equivalent in pharmacy or life-science
Minimum 6 years pharmaceutical R&D experience including 2+ years regulatory
Experience in health authority interactions
Knowledge of Japanese regulations
Business-level English and Japanese communication skills