医薬品メーカー

開発薬事担当者（ノンラインマネージャー）

※ノンラインマネージャーでの採用となります。

【職務概要】※詳しくはキャリアアドバイザーまでお問い合わせください。
The manager of RRL JP provides strong leadership to develop and implement regulatory strategy for the assigned products/projects as RRL JP, and exercises activities which include:

An integral member of the Regulatory Excellence Team, a contact point of Global Regulatory Lead (GRL), responsible for a particular therapeutic area(s), contributes to the delivery of robust regulatory strategies, leads task team for J-CTD, and coordinates local regulatory activities for the assigned development projects and marketed products for Japan to enable timely submissions and approvals.

Interface & contact partner for the Japanese regulatory authorities for development products including those undergoing PMDA consultation as well as marketed products, Global RA and other cross functional stakeholders for product and project related regulatory activities for the assigned therapeutic area(s).

Regulatory expert for the regulatory requirements in Japan.

Support Head of Development RA regarding specific projects and activities..

Act as Regional Regulatory Lead Japan for assigned products/projects and be a trusted partner to health authorities as well as Boehringer Ingelheim.

※リモートワーク回数の制限はありませんが、社員の方は週1回程度オフィス出社される方が多いです。