Company Overview
A leading clinical research provider specializing in drug development and clinical trial services across various therapeutic areas. It supports pharmaceutical and biotechnology companies by delivering high-quality, reliable data and operational excellence from early-phase studies to post-marketing research. The company combines global expertise with local knowledge to advance medical innovation and improve patient outcomes.
Position Overview
Prepare, update, and manage Clinical Trial Notifications (CTNs) and associated regulatory documentation.
Serve as a liaison with regulatory authorities such as PMDA and MHLW.
Support the preparation and submission of marketing authorization applications for clients.
Collect, organize, and maintain regulatory data for compliance and reporting purposes.
Participate in internal meetings, training programs, and other assigned responsibilities.
Requirements
Minimum of 3 years’ experience preparing and submitting Clinical Trial Notifications, including direct interactions with PMDA.
At least 3 years of regulatory affairs experience related to new pharmaceutical or regenerative medicine products, covering CMC, non-clinical, and clinical aspects, as well as CTD/eCTD preparation and submission.
Bachelor’s degree or higher in a science-related field.
Proficiency in English equivalent to a TOEIC score of 750+, with strong speaking skills, as client meetings are held roughly once a week.