• Planning and formulation of regulatory affairs strategies and clinical trial/approval application strategies for clinical development plans; safety management.

• Oversight of all safety management and quality assurance operations.

• Applications and notifications for regulatory approval/certification, etc.

36-1 Yoshida Honmachi, Sakyo-ku, Kyoto City, Kyoto Prefecture (12-minute walk from Keihan Demachiyanagi Station)

Remote work available.

• Possess relevant experience suitable for this position.

• Age: Not specified

• Education: Master's degree or higher

• Work Experience: 5+ years required

• Industry Experience: Required

• English Proficiency: Intermediate or higher

• Employment Type: Full-time employee

• Probationary Period: Yes (6 months)

• Salary: Negotiable based on skills and experience

• Commuting Allowance: Fully covered (with a cap)

• Social Insurance: Health insurance, employee pension, employment insurance, worker's accident insurance

• Working Hours: 9:30 AM - 6:30 PM (60-minute break), approximately 10-20 hours of overtime per month

• Holidays: 120 annual holidays, full two-day weekend system (annual paid leave, other congratulatory/condolence leave available)