Associate Manager, CMC Regulatory Affairs

Regeneron · Tokyo

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RegulatoryFull-timeCompany career page

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What they're looking for

Bachelor's degree in scientific discipline; Master's degree preferred
10+ years regulatory CMC experience with health authority interactions and major submissions
Experience supporting CTN, J-NDA, eCTD submissions and PMDA responses
Deep knowledge of Japanese regulatory requirements and guidance documents
High fluency in both Japanese and English languages
Ability to obtain and maintain Foreign Manufacturing Accreditation or Registration

What you'll be doing

Support planning, scientific writing, and review of regulatory submissions for CTN, J-NDA, and eCTD supplements
Prepare Japanese application forms and regulatory dossiers for biopharmaceutical submissions
Act as local liaison with PMDA for CMC submissions and information requests
Assess CMC change controls against regulatory filings to ensure compliance
Monitor project timelines to ensure on-time regulatory submissions

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RoleLantern checked active

RoleLantern checkedNeeds clarity

Date posted4 days ago

Last source check1 day ago

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