Regulatory Officer

As a Regulatory Officer, you will work closely with our global team of experts to prepare clinical trial dossiers for regulatory 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.

Location: Tokyo preferred (Osaka or remote within Japan is negotiable)

Level: Open from Junior to Mid level candidates

• 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 r...