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 Principal Scientist works in CMC Sciences within Regulatory Affairs, leading CMC regulatory activities for pharmaceutical development and product lifecycle management. The position combines Japan CMC-RA strategy with team oversight, coordinating resources and timelines and contributing Japan-specific input to global and post-marketing plans.
The role prepares pre- and post-approval CMC dossiers and consultation documents, checking writing, review, QC and compliance and reviewing team documents. It answers PMDA CMC questions, communicates with PMDA officials when needed, manages approved-product change control, supports GMP/compliance inspections, assesses revised CMC regulations, and joins task forces and external industry activities.
Applicants need at least seven years of CMC-related pharmaceutical-industry experience, familiarity with Japan CMC regulatory notifications, and either Japanese NDA completion as a CMC-RA representative or team leader, or experience with regulatory procedures in pharmaceutical research or CMC operations. They also need to discuss CMC regulatory topics with global members in English and hold a bachelor’s, master’s or Doctor of Science degree.
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