Regulatory Officer at PSI CRO

Tokyo, , Japan -

Full Time

Start Date

Immediate

Expiry Date

13 Sep, 26

Salary

0.0

Posted On

15 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Submissions, PMDA Regulations, Regulatory Dossier Preparation, English Proficiency, Japanese Proficiency, Communication, Collaboration, Problem-solving, Detail-oriented, Safety Reporting, Legislative Tracking, Stakeholder Management

Industry

Pharmaceutical Manufacturing

Description

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, 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.

Responsibilities

The Regulatory Officer prepares clinical trial dossiers for regulatory authorities and manages communications with stakeholders, sponsors, and vendors. They are also responsible for tracking legislative changes in Japan and delivering regulatory training to project teams.