Job Description

This position primarily supports the new product development in Japan by giving the latest regulatory information in Japan to the global and local development teams and also communicating with the global development teams and global RA.

Major Accountabilities

l Preparing regulatory development plans/strategies for each project

l Providing information on the latest regulatory requirements in Japan and giving advice to the development teams, etc. based on the latest regulatory requirements in Japan

l Chairing/facilitating meetings/negotiations with the HAs such as PMDA consultation meetings, and establishing/keeping good relationship with the HAs

l Preparing regulatory documents to be submitted to the HAs and other necessary documents in collaboration with other development team members

Experience/Professional Requirement:

l BA in pharmaceuticals and/or sciences.

l Advanced degree is preferable.

l English both spoken and written

l Japanese as fluent

l Significant experience (>5 years) in RA for new drug development, preferably being involved in RA strategy function, in global/new drug/innovative drug companies

l Working experience with global pharmaceutical companies required.

l Negotiations/meetings with the HAs such as PMDA consultation meetings as a facilitator and/or leader

l Team oriented

l Age from late 30’s to mid 40’s