The Director, Regulatory Affairs provides key support to the North American and global Regulatory Affairs teams. This position has primary responsibility for providing input into and managing regulatory documents for review and submission to North American regulatory agencies and other regulatory agencies (as requested). The position will oversee Regulatory budgets, CMC, and Labeling activities,identify, select, and manage internal/external subject matter experts and key opinion leaders as need be to support submissions of the highest quality for INDs, BLAs, NDA/S global marketing applications, briefing packages, annual reports, safety reports, amendments, and supplements. Specific Responsibilities:In partnership with the VP, US Regulatory Affairs participate in
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