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.
Based in Tokyo
- 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