The Senior Manager serves as the Japan regulatory lead responsible for formulating strategies to align global development plans with local requirements
Job Summary
The Senior Manager serves as the Japan regulatory lead responsible for formulating strategies to align global development plans with local requirements.
This role involves leading PMDA interactions, preparing major submissions like CTNs and J-NDAs, and ensuring high-quality regulatory compliance.
The position offers a direct impact on accelerating patient access to innovative therapies in Japan through close engagement with regulatory authorities.
Matching Summary
The Senior Manager serves as the Japan regulatory lead responsible for formulating strategies to align global development plans with local requirements.
Skills & Requirements
Must-have
Native-level Japanese language proficiency
PMDA consultation meeting leadership
J-CTD module preparation expertise
Japan regulatory strategy formulation
Cross-functional team collaboration
Nice-to-have
Experience with CTD/eCTD preparation
Strong logical and analytical thinking
Proactive problem-solving mindset
Influence without authority skills
Global regulatory team representation
Key Requirements
Bachelor's degree or higher in scientific field
Minimum 2 years experience in R&D or Regulatory Affairs