Company Description

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 long-standing traditions and history. Our expansion into Japan continues this legacy, and we seek team members who will grow with us for the long term.

At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.

We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.

Job Description

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, Osaka or Sapporo

Prepare clinical trial regulatory submission dossiers, including applications for import and export licensesTrack regulatory project documentation flow and progress reportingReview translations of essential documents subject to clinical trial submissionLiaise with project teams to procure documents necessary for regulatory submissionsCommunicate with regulatory authorities, sponsors, and vendors on all regulatory-related mattersTrack changes/amendments to legislative acts pertaining to clinical trials in JapanReview documents to greenlight IP release to sitesManage safety reporting to authoritiesDeliver training on regulatory environment in JapanParticipate in the regulatory aspects of feasibility research

 

QualificationsUniversity degree in Life Sciences, Medicine or Pharmacy or an equivalent combination of education, training, and experienceExperience with clinical trial submissions to PMDAKnowledge of the regulatory environment for clinical researchFull working proficiency in English and JapaneseDetail-orientedCommunication, 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.