Regulatory Affairs CMC Manager (Japan)

Location: Must be based in Tokyo, Japan (Hybrid role)

Company

hirify.global is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.

What you will do

• Plan and manage regulatory submissions for clinical development and marketing applications in Japan.
• Develop CMC regulatory strategies and identify development gaps to ensure drug product approvability.
• Prepare and review CMC documentation for meetings with the PMDA.
• Interpret PMDA and global regulations (ICH, WHO, ISO) to ensure internal compliance.
• Collaborate with scientists to resolve technical issues in drug substance synthesis, impurities, and formulation.
• Communicate and negotiate directly or indirectly with regulatory authorities in Japan.

Requirements

• Minimum 3 years of pharmaceutical Regulatory CMC experience in multinational companies.
• Solid understanding of PMDA regulations for drugs and biologics.
• Proven ability to liaise with PMDA as a lead in agency interactions.
• Fluent in both Japanese and English (verbal and written).
• Bachelor's or Master’s degree in pharmacy, nursing, healthcare, or life sciences.
• Must be based in Tokyo with ability to work from the office.

Culture & Benefits

• Flexible working hours and comprehensive leave policies.
• Attractive compensation including retirement benefits and stock options (ESPP).
• Extensive career development support including LinkedIn Learning and professional training.
• Modern hybrid work environment with advanced IT support.
• Collaborative office space in central Tokyo with free-address seating.