薬事・規制関連業務担当者（Regulatory Officer）

【求人No NJB2327428】
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

・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