My client is a large international biopharmaceutical company with a presence across more than 100 countries. They specialize in helping companies with late-stage clinical trials, clinical development, and medical affairs.
They are currently looking for a Regulatory Consultant/Manager in Japan.
Highlight: Top 5% retention rate in Japan
Location: Tokyo/Remotely in Japan
Responsibility :
- Gap analysis for CMC, pre-clinical & clinical data/reports to start clinical study / submit NDA in Japan
- Strategy development, including 2nd opinion on clients' regulatory strategy / high-level clinical development plan
- PDMA consultation and negotiation. Official meeting with Japanese regulatory authorities at important milestones (e.g. pre-phase 1 study, end of phase 2 study)
- ICCC sponsors
Requirements:
- Background in Pharma/CRO/Biotech
- Native Japanese and fluent English
For further information about this position please apply.
