Regulatory Officer

Job Description

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 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 the regulatory environment in Japan
• Participate in the regulatory aspects of feasibility research

Qualifications

• 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 (Japanese and English), collaboration, and problem-solving skills

Additional Information

How are we different?

PSI is privately owned by the very people who founded the company more than 25 years ago, and they’re still working here today. As a result, we have grown organically around the globe and have kept our company fully independent, giving us significant advantages and freedoms.  

Being a Part of the Team

As a part of the PSI team, you will have a fair degree of ownership and autonomy to make nuanced country-and department-specific adjustments while nurturing the global PSI culture that unites us across six continents.

You will receive continuous support from your global peers and join a fast-paced, innovative, and results-oriented working environment with lean communication lines. We pride ourselves on being approachable, receptive to new ideas, and open to feedback.

Growth Opportunities

PSI is proud to invest in our people, from entry-level team members to senior leaders, helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.

PSI is an inclusive and equal opportunity employer and is committed to attracting and retaining a diverse workforce that reflects the community we serve.