The incumbent is accountable for the strategic management of a portfolio of development projects and post-marketed products within Global regulatory CMC & Devices Japan
Job Summary
The incumbent is accountable for the strategic management of a portfolio of development projects and post-marketed products within Global regulatory CMC & Devices Japan.
Responsibilities include developing innovative Japan regulatory CMC strategies, managing submission dossiers, and maintaining direct contact with PMDA and MHLW.
The role requires collaborating with global and local teams to ensure compliance with Japanese regulations while supporting business needs through pragmatic regulatory positions.
Matching Summary
The incumbent is accountable for the strategic management of a portfolio of development projects and post-marketed products within Global regulatory CMC & Devices Japan.
Skills & Requirements
Must-have
Japan regulatory CMC strategies
PMDA/MHLW liaison experience
Regulatory dossier preparation
CMC change control management
Health authority negotiations
Nice-to-have
Mentoring and training staff
Experience with global regulatory operations
Insight into industry association activities
Technical pharmaceutical CMC background
Prior health authority employment
Key Requirements
Minimum Bachelor's degree in science or health field
Minimum 3 years of direct Regulatory CMC experience
Business level English fluency (oral and written)
Knowledge of Japan and global regulations/guidelines