Associate Manager, CMC Regulatory Affairs (Biotech)

Location: Tokyo, Japan; hybrid work model

Company

hirify.global is a science-driven biopharmaceutical company developing medicines for people with serious diseases.

What you will do

• Support regulatory CMC strategy and prepare, write, and critically review CTN, J-NDA, and eCTD supplement submissions.
• Prepare Japanese application forms and regulatory dossiers.
• Collaborate with Global Regulatory CMC, Regulatory CMC Science, and cross-functional teams on regulatory decisions.
• Act as the 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.
• Monitor project timelines and support on-time submissions and regulatory communications.

Requirements

• Bachelor's degree in a scientific discipline; a Master's degree is preferred.
• Strong biopharmaceutical and regulatory Chemistry, Manufacturing and Controls (CMC) 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.
• High fluency in Japanese and English is required, along with the ability to obtain and maintain Foreign Manufacturing Accreditation or Foreign Manufacture Registration.

Culture & Benefits

• Collaborative environment with communication across global teams.
• Inclusive workplace and equal employment opportunity commitment.
• Competitive total rewards may include bonuses or incentive plans, equity awards, retirement benefits, insurance, paid time off, and family support benefits, depending on country and role.
• Background checks may verify identity, right to work, and educational qualifications where permitted by local law.