Manager, CMC Regulatory Affairs (Japan)

Location: Tokyo, Japan; hybrid work model.

Company

A science-driven biopharmaceutical organization developing medicines for people with serious diseases.

What you will do

• Lead planning, scientific writing, and critical review of CTN, J-NDA, and eCTD supplement submissions.
• Prepare Japanese application forms and support high-quality regulatory dossiers.
• Drive regulatory decisions and manage submission timelines across cross-functional teams.
• Act as a local liaison with PMDA for CMC submissions, information requests, and agency meetings.
• Assess CMC change controls and review manufacturing processes and specifications against approved filings.
• Communicate regulatory positions, interpret feedback, and build effective partnerships across global and local teams.

Requirements

• Bachelor's degree in a scientific discipline; a master's degree is preferred.
• Strong biopharmaceutical and regulatory Chemistry, Manufacturing and Controls (CMC) background.
• 15+ years of regulatory CMC experience, including health authority interactions, major submissions, and approvals in Japan.
• Experience leading CTN, J-NDA, eCTD, PCA, and MCN submissions and PMDA responses.
• Deep knowledge of Japanese regulatory requirements, guidance documents, and regulatory resources.
• High fluency in Japanese and English, with strong communication, strategic thinking, and collaboration skills.

Culture & Benefits

• Inclusive workplace focused on collaboration and equal opportunity.
• Comprehensive rewards may include bonuses, equity awards, pension or retirement benefits, insurance, paid time off, and family support benefits.
• Background checks may verify identity, right to work, and educational qualifications in accordance with local law.