Senior Manager, CMC Regulatory (CMC Senior Expert, CMC Regulatory)
Bristol Myers Squibb · Otemachi-JP
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Role summary
This senior regulatory affairs position oversees CMC regulatory strategy and execution for drug development and approval in Japan. The role involves leading PMDA interactions, preparing regulatory submissions and CTD documents, managing manufacturing changes, and mentoring team members. Requires 10+ years of pharmaceutical regulatory experience, strong technical knowledge in GMP/quality systems, fluent English, and demonstrated leadership skills.
Privacy & handoff
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