Regulatory Strategy Specialist
Core
Develop and execute regulatory strategies for new product registrations and lifecycle management in Japan, ensuring timely approvals and uninterrupted product supply.
Role type
Senior Regulatory Strategy Specialist
Builds
Innovative therapies for patients in immunology, hematology, cardiovascular, metabolic, respiratory, and transplant areas
Domain
Pharmaceutical/Biotechnology, Japan market
Required skills
Drug development strategy, PMDA interaction, regulatory submission preparation, clinical development understanding, cross-functional collaboration, Japanese communication, English communication
Preferred skills
Regulatory Affairs experience, Japanese drug development knowledge, PMDA consultation experience, global development program experience, therapeutic area expertise, advanced scientific/medical degree
Technologies
CTD, NDA, CTN, Orphan Drug Designation
Responsibilities
Develop Japan-specific regulatory strategies, lead PMDA interactions, prepare and review regulatory submissions, evaluate regulatory pathways, collaborate with global teams
Seniority
Senior, hands-on IC