Associate Manager, CMC Regulatory Affairs

Location: Tokyo, Japan; hybrid work mode

Company

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

What you will do

• Support regulatory CMC strategy and submissions across therapeutic areas.
• Plan, write, and critically review CTN, J-NDA, and eCTD supplement submissions.
• Prepare Japanese application forms and regulatory dossiers.
• Act as a local liaison with PMDA for CMC submissions and information requests.
• Assess CMC change controls against regulatory filings and review manufacturing processes and specifications for investigational product release requests.
• Coordinate timelines and collaborate with Global Regulatory CMC, Regulatory Science, and cross-functional teams.

Requirements

• Bachelor's degree in a scientific discipline; a master's degree is preferred.
• Strong biopharmaceutical and regulatory Chemistry, Manufacturing and Controls background.
• 10+ years of regulatory CMC experience, including health authority interactions, major submissions, and approvals in Japan.
• Experience with CTN, J-NDA, eCTD submissions, PCA, MCN, and PMDA responses.
• Knowledge of Japanese regulatory requirements, guidance documents, and regulatory resources, with experience participating in agency meetings and supporting regulatory communications.
• High fluency in Japanese and English; ability to obtain and maintain Foreign Manufacturing Accreditation or Foreign Manufacture Registration.

Culture & Benefits

• Collaborative, science-driven environment with cross-functional global teams.
• Inclusive workplace and equal opportunity employment.
• Competitive total rewards package that may include bonuses, equity awards, pension or retirement benefits, insurance, paid time off, and family support benefits.
• Background checks may be conducted to verify identity, right to work, and educational qualifications.