メディカル・バイオ - 臨床開発リーダー・臨床開発プロジェクトマネージャー
メディカル・バイオ - 薬事申請

This position reports directly to the Vice President who is responsible to manage all resources and budgets for global activities initiation, and reports dotted to President and works together to present/discuss regulatory strategy with key stakeholders. This position will lead designing regulator strategy global together with Business Unit Head, BU Head, who is responsible to lead an asset team. This position will be a liaison with oversea’ regulatory authorities for obtaining regulatory’ buy-in and support clinical trial execution outside of Japan. This position is individual contributor in principle, however, will work closely with the local regulatory specialist who works as local liaison for PMDA in Japan and reports to in-charged BU Head.

Qualifications
1. BA/BS degree required
2. Minimum 10+years of overall business experience
3. Minimum 5+years of R&D regulatory experience including lead liaison
assignment for outside Japan regulatory filing and IND management, such as
in US.
4. Preferable experience to discuss any priority/acceleration discussion with
regulatory authorities
5. Must be able to partner effectively and influence at all levels in a matrix
environment with strong interpersonal skills and effectiveness.

■職種未経験者：不可