薬事・規制関連業務担当者(Regulatory Officer)
- 採用企業名
- PSI CRO Japan株式会社
- 職種
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メディカル・バイオ - 薬事申請
- 雇用形態
- 無期雇用
- 勤務地
-
大阪府 東京都
- 仕事内容
-
...
As a Regulatory Officer, will work closely with our global team of experts to prepare clinical trial dossiers for regulatory and authorities, deliver regulatory training to project teams, and communicate with stakeholders on regulatory-related matters.
Join PSI and help drive innovation and excellence in advancing healthcare solutions.
Prepare clinical trial regulatory submission dossiers, including applications for import and export licenses
Track regulatory project documentation flow and progress reporting
Review translations of essential documents subject to clinical trial submission
Liaise with project teams to procure documents necessary for regulatory submissions
Communicate with regulatory authorities, sponsors, and vendors on all regulatory-related matters
Track changes/amendments to legislative acts pertaining to clinical trials in Japan
Review documents to greenlight IP release to sites
Manage safety reporting to authorities
Deliver training on regulatory environment in Japan
Participate in the regulatory aspects of feasibility research■休日:完全週休二日制, 土, 日, 祝日, 年末年始
- 求める経験
-
...
・University degree in Life Sciences, Medicine or Pharmacy or an equivalent combination of education, training, and experience
・Experience with clinical trial submissions to PMDA
・Knowledge of the regulatory environment for clinical research
・Full working proficiency in English and Japanese
・Detail-oriented
・Communication, collaboration, and problem-solving skills■職種未経験者:不可
- 想定年収
- 600万円 - 1000万円
- 語学力
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英語力:中級以上




