Lead Japanese regulatory strategy and target labeling in J-CDT, and share the information to the Global Regulatory Team (GRT)
Job Summary
Lead Japanese regulatory strategy and target labeling in J-CDT, and share the information to the Global Regulatory Team (GRT).
Lead Japanese Health Authority (HA) response such as PMDA consultation/ preliminary meeting, MHLW meeting related the development of compound.
Provides input into strategy with respect to clinical study design for local studies and develops and updates contingency plans for regulatory strategies as they pertain to Japan.
Matching Summary
Lead Japanese regulatory strategy and target labeling in J-CDT, and share the information to the Global Regulatory Team (GRT).
Skills & Requirements
Must-have
Japanese regulatory strategy
HA response and negotiation
CTD preparation and submission
Japanese target labeling
Global regulatory team collaboration
Nice-to-have
Proactive team player
Achievement-oriented
Adaptable to changing environment
Flexibility for time zone differences
Key Requirements
Bachelor's degree or equivalent in pharmacy or life-science