医薬品メーカー

添文安全情報薬務担当者（薬制薬事）

※スタッフまたはノンラインマネージャーでの採用となります。
【募集背景】
組織強化による増員

【職務概要】※詳細はアドバイザーまでお問い合わせください。
The manager of Regional Regulatory Lead of Electronic Package Insert and Safety Related Information Operation Japan [RRL JP PSO] has responsibilities for labeling management of J-Package Insert, and management of the operations in submission of PI and Health Authority Interaction (HAI) as liaison of health authorities on safety related information (SRI), as follows.

(1) Provision of strong leadership as the leader of task team J-Package Insert and adhere e-PI implementation and labeling compliance.
(2) Adhere regulatory compliance with reporting requirements on safety obligation tasks, for examples HAI, record, and tracking (Quality and Compliance for Safety Related Information to Health Authorities or SRIQC).
(3) Provide PI and safety-related information to relevant Boehringer Ingelheim stakeholders where needed (Precautionary information, PV System Master File, Webpostings, etc.).

Interface & contact partner for the Japanese regulatory authorities, Global RA, as well as License Partner and other cross functional stakeholders for managing the operations in submission of PI and Health Authority Interaction (HAI) on safety related information (SRI) and coordinates local regulatory activities for the assigned development projects and marketed products for Japan to enable timely submissions and approvals.
- Regulatory expert for the regulatory requirements in Japan.
- Provide supports RRL JP and LSPV managers who manage the contents by implementing operations in PI and HAI.
- Provide supports RRL JP and Regulatory Excellent Team (RET) to coordinate and develop package inserts based on CCDS and target product profiles for Japan, where applicable.

※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。