CMC薬事マネージャー

Job Details

職務内容:

<New submissions>
・Communicate with Global Regulatory & Development (R&D) team and prepare submission dossier (especially CMC related parts) and submit to MHLW/PMDA.
・Prepare documents for raw data review and GMP compliance review.
・After submission, prepare and review answers to PMDA inquiries for timely approvals based on CMC expertise.
<Development projects>
・Establish regulatory strategies of specialized products by close collaboration with R&D team. Conduct PMDA consultations.
・Review and give guidance to R&D team proposals in development activities based on knowledge of CMC and its Japanese regulations.
<Regulatory maintenance and other regulatory activities>
・Support any required regulatory activities including dossier preparation of Partial Change Applications and Minor Change Notifications.

応募要件:

・新薬またはジェネリック医薬品の新規申請において、CMC 薬事業務の経験がある方
申請前の薬事戦略の作成、PMDA 対面助言
承認申請から照会対応、承認取得までの一連の業務経験(CTD 作成経験要)
特にグローバル開発されたジェネリック医薬品の承認申請関連業務経験があることが好ましい
・注射剤、点眼剤等の無菌製剤の経験があることが好ましい
・GMP 適合性調査対応の経験があることがなお好ましい
・QA・QC 部門の経験、製剤開発部門、生産技術研究部門の経験も考慮可
・疾患領域は特に問わない
・グローバル開発された薬剤について、グローバルの関連部門と協働し日本における申 請・承認取得を担当した経験があることが好ましい
・グローバルの担当者とメールで適切にコミュニケーションできる英語力必須。電話会 議、ビデオ会議で議論できる会話力があれば尚可。

Job application

Apex delivers strong profile and highly skilled candidates that match the job description requirements. Their candidate know how, network and experience helped us to initiate contact and integrate the candidate into our company. We are very happy with the candidate selected by Apex. K.K. consulting service. Thank you for the professional recruitment consulting service throughout the selection and follow up. We really appreciated it and strongly recommend Apex.

APAC Head of Supply Chain

Global Healthcare Company