品川・大崎の薬事(薬事申請)の転職・求人情報

外部就労型／当社に正社員で入社しクライアント先にて勤務頂きます。薬事業務■開発に係る規制（CMC、非臨床試験、臨床試験）の適正な解釈、効率的な開発計画案の企図■海外データのギャップ分析■PMDA相談資料の作成ならびにPMDAからの照会対応■医薬品等の治験届出や添付文書等改訂及び当局対応■国内行政通知等情報の収集・分析及び社内関連部門への提供と対応など

外部就労型／当社に正社員で入社しクライアント先にて勤務頂きます。【具体的には】■治験ならびに製造販売後臨床試験等に関する資料作成(治験計画届、試験実施計画書、同意説明文書、治験薬概要書等)■臨床試験における報告書作成(治験総括報告書、臨床試験報告書)■承認申請、再審査申請のための資料作成(CTDに対応した申請資料、再審査申請資料)■インタビューフォーム作成または改訂■英文報告書の和訳■各種報告書、申請書類の英訳　　等

※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.

※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.