薬事・規制関連業務担当者（Regulatory Officer）

PSI CRO Japan株式会社

外資系企業マネジメント業務なし英語力が必要土日祝休み

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募集要項

仕事内容: PSI CRO Japan株式会社での募集です。
薬事申請のご経験のある方は歓迎です。
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 tra…

応募資格

必須: ・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

フィットする人物像: JAC Recruitmentでは、担当コンサルタントが直接企業へ訪問。だからお伝えできることがあります。
面談の際に、採用担当者からお聞きした情報やコンサルタント自身が感じた選考のポイントを皆さまへお届けします。

事業内容・会社の特長: PSI is a leading Contract Research Organization （CRO） with over 25 years of experience in the pharmaceutical industry. Originating from Switzerland PSI is a privately owned full service CRO with a global reach supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high quality timely services across a broad spectrum of therapeutic indications.

In an industry where cost cutting and layoffs are common PSI stands out as a stable and secure workplace. Our dedication to stability is evident in our exceptionally high repeat and referral business rate and minimal staff turnover. Many of our colleagues have been with us for over 15 years contributing to our …

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厚生労働大臣許可番号：13-ユ-010227紹介事業許可年：1988年

紹介事業事業所: 東京本社・北海道支店・東北支店・北関東支店・横浜支店・静岡支店・浜松支店・名古屋支店・京都支店・大阪支店・神戸支店・中国支店・福岡支店