Key Responsibilities
Prepare, update, and manage Clinical Trial Notifications (CTNs) and related regulatory documentation
Coordinate consultations with regulatory authorities such as the PMDA and MHLW
Support clients in preparing and submitting marketing authorization applications
Collect, organize, and maintain regulatory information and documentation
Supervise and manage team members within the regulatory affairs department
Participate in internal meetings, training sessions, and other assigned activities
Required Qualifications
Approximately 5 years of experience preparing and submitting CTNs, including direct involvement in PMDA consultations
Around 5 years of regulatory affairs experience in the development of new pharmaceuticals or regenerative medicine products, covering CMC, non-clinical, and clinical components, as well as CTD/eCTD dossier preparation and submission
At least 3 years of experience managing and supervising regulatory affairs personnel
Bachelor’s degree or higher in a science-related field
Strong English communication skills, with a recent TOEIC score of 800+ or equivalent proficiency
Ability to conduct weekly client meetings in spoken English