From US to Japan
Sometimes your office has the best view ever...A new project on the horizon, brings us to the land of the Rising Sun.
This new project, exploring and building strategies -with regulatory affairs - to bring a product to the market in Japan. Demanding when it comes to setting meeting schedules, answering the clients needs - putting my normal day schedule upside down. Yet challenging, this project is so exiting, giving opportunity to connect, work with a team located in Tokio. I simply learned to love this culture and country so much.
Project includes strategy setting, preparations and conduct of formal and informal meetings with PMDA in the offices in Tokio. Follow up on feasibility feedback, development and implementation of operational processes needed to prepare for data to be included in the Shonin submission.