Job 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

You will lead regulatory affairs services related to the global clinical trials in Japan. Join our team of regulatory experts and contribute to groundbreaking clinical research.

Based in Tokyo. Hybrid 

The scope of responsibilities will include:

• Develop submission strategies, review project planning documents & processes, and plan study regulatory timelines in Japan
• Assess regulatory aspects of study feasibility, support Business Development team in winning new studies for the region
• Prepare clinical trial submission dossiers for Regulatory Authorities, including Import and Export license applications
• Communicate with regulatory authorities, project teams and vendors on regulatory-related matters
• Review translations of essential documents subject to clinical trial submission
• Track regulatory project documentation flow
• Track changes/amendments to legislation requirements related to clinical research
• Develop and maintain regulatory requirements database
• Ensure accurate and time-bound reporting of safety issues to local authorities
• Review documents to greenlight IP release to sites
• Deliver training on regulatory environment in Japan
• Line management of Regulatory Affairs staff in Japan

Qualifications

• University degree in Life Sciences, Medicine or Pharmacy or an equivalent combination of education, training, and experience
• Minimum 7-10 years’ experience with clinical trial submissions to PMDA
• Knowledge of the regulatory environment for clinical research in Japan
• Full working proficiency in English
• Communication, collaboration, and problem-solving skills
• Leadership and people management skills

Additional Information

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

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