Senior Director, Regulatory Affairs (Japan)

Location: Tokyo, Japan; hybrid work model.

Company

hirify.global is a biotechnology company that discovers, develops, and commercializes medicines for serious diseases.

What you will do

• Plan and execute Japan regulatory strategies, including Japan NDAs and consultations with PMDA.
• Lead NDA submissions, approvals, post-approval changes, and lifecycle management.
• Support management of the Japan Regulatory Affairs function with local and global leadership.
• Oversee interactions with Japanese regulatory authorities and lead or support clinical trial notification submissions to PMDA.
• Represent Regulatory Affairs on multidisciplinary clinical, medical, commercial, and patient safety teams.
• Develop local labeling and patient information and review promotional materials.

Requirements

• Bachelor's degree in a scientific discipline; a master's degree is preferred and a doctoral degree is advantageous.
• Strong experience in development and regulatory strategy roles, with a demonstrated track record delivering Japan NDAs.
• Deep knowledge of Japan clinical development requirements, submission requirements, regulations, and local standards.
• Business-level English fluency required.
• Strategic thinking, commercial awareness, strong written and verbal communication skills, and success in global matrix environments.

Nice to have

• People management experience.

Culture & Benefits

• Hybrid work model with onsite expectations determined for the role and location.
• Inclusive workplace and equal opportunity employment.
• Benefits may include incentive plans, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits, depending on country and role.