Senior Manager, Regulatory Affairs

Location: Japan; hybrid work model.

Company

hirify.global develops medicines for people with serious diseases through science and innovation.

What you will do

• Plan and execute Japan regulatory strategies and PMDA consultations across assigned programs.
• Lead marketing application and post-approval change submissions.
• Manage interactions with PMDA and other Japanese health authorities.
• Lead or support clinical trial notification preparation and submissions.
• Represent Regulatory Affairs across clinical, commercial, medical, and patient safety functions.
• Support local labeling, patient information, and promotional material reviews.

Requirements

• Bachelor's degree in a scientific discipline; a Master's degree is preferred.
• 10+ years of pharmaceutical industry experience and 5+ years of relevant regulatory experience.
• Experience managing Japanese health authority interactions, major submissions, and approvals.
• Deep knowledge of Japan submission requirements, local regulations, and regulatory standards.
• Knowledge of clinical trial requirements, business start-up activities, and local procedural challenges.
• Fluent Japanese and English language skills required.

Culture & Benefits

• Work in a science-driven organization focused on developing life-changing medicines.
• Collaborate with global regulatory teams and local cross-functional partners in a matrix environment.
• Benefits may include bonuses, equity awards, retirement benefits, insurance, paid time off, and family support benefits, depending on country and role.
• Reasonable accommodation is available during recruitment where required.

Hiring process

• Background checks may verify identity, right to work, and educational qualifications in accordance with Japanese law.
• Final compensation and applicable benefits are determined based on the country of employment, role level, skills, and experience.