Associate Manager, CMC Regulatory Affairs
Core
Support regulatory CMC strategy and submissions for the Japan organization, including planning, scientific writing, and critical review of CTN, J-NDA, and eCTD supplements.
Role type
Associate Manager, CMC Regulatory Affairs
Builds
Regulatory dossiers and submissions for biopharmaceutical products in Japan
Domain
Biopharmaceuticals / Regulatory Affairs / Chemistry, Manufacturing, and Controls (CMC)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> regulatory filings
Required skills
CMC regulatory strategy, scientific writing, critical review of submissions, Japanese regulatory requirements knowledge, agency meeting support, Foreign Manufacturing Accreditation/Registration management, change control assessment, manufacturing process/specification review, project timeline monitoring
Preferred skills
Master's degree in a scientific discipline
Technologies
CTN, J-NDA, eCTD, PMDA systems
Responsibilities
Support planning, scientific writing, and critical review of 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; Review manufacturing processes and specifications for investigational product release requests; Monitor project timelines to support on-time regulatory submissions
Seniority
Associate Manager, hands-on IC
