Leads APAC surgery professional education strategy, faculty development, cross-country collaboration, and delivery of programs for healthcare professionals across the region.
About this role
This scientist sits in the CMC Group within CMC Sciences and Regulatory Affairs, supporting pharmaceutical development and product lifecycle management. The role prepares CMC submissions and supports regulatory approval.
Work includes preparing pre- and post-approval CMC dossiers and consultation documents; writing, reviewing and quality-checking regulatory materials; answering PMDA questions; managing approved-product change control; and supporting GMP/compliance inspections. The role assesses revised CMC regulations, contributes to Japan NDA strategy, and coordinates with global and cross-functional stakeholders.
Applicants need at least five years of CMC-related pharmaceutical-industry experience, familiarity with Japanese CMC regulatory notifications, and either Japanese NDA completion as a CMC-RA representative or team leader, or experience in pharmaceutical research regulatory procedures or CMC operations. A science bachelor’s, master’s or doctorate and the ability to discuss CMC regulatory topics in English are required.
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