Associate Director, Regulatory CMC

Location: Tokyo, Japan office with weekly hybrid-work flexibility; approximately 10% domestic and international travel required.

Company

hirify.global is a global biopharmaceutical company developing medicines for patients with serious and rare diseases.

What you will do

• Plan, execute, and manage Japanese regulatory CMC submissions across clinical development, marketing applications, and post-approval lifecycle activities.
• Develop regulatory strategies and identify CMC development gaps and challenges affecting product approvability in Japan.
• Prepare plans and draft or review documents for CMC meetings with Japanese regulatory agencies.
• Interpret PMDA, ICH, WHO, ISO, and other applicable regulations to support CMC compliance.
• Collaborate with scientists on drug substance synthesis, impurities and degradation products, formulation, and device combination product development.
• Communicate and negotiate with PMDA and advise internal and external stakeholders on regulatory requirements.

Requirements

• At least three years of pharmaceutical Regulatory CMC experience in a multinational company, including experience as an RA CMC product lead or equivalent.
• Strong understanding of PMDA regulations for drugs and biologics and the ability to compare regulatory requirements across regions.
• Experience leading PMDA interactions and product development meetings.
• Understanding of scientific principles and regulatory CMC requirements for global development and post-market lifecycle support.
• Fluent written and verbal Japanese and English required.
• Bachelor’s or Master’s degree in pharmacy, nursing, another healthcare-related profession, or life sciences.

Nice to have

• Experience developing and implementing new processes.
• Experience working through ambiguous CMC regulatory issues and influencing cross-functional stakeholders.

Culture & Benefits

• Flexible working hours and comprehensive leave programs.
• Retirement, stock compensation, and employee stock purchase plan opportunities.
• Internal and external training, LinkedIn Learning, and role-specific professional development.
• AI-supported learning tools and digital assistant access to internal resources.
• Hybrid-work environment with technology and IT support for collaboration across locations and time zones.