The Global Regulatory Affairs Program Lead is a talented, seasoned, and motivated regulatory affairs leader who will create and execute global regulatory strategies aimed at the most efficient regulatory pathway for a rare disease drug, including Orphan Drug, Fast Track and Breakthrough Therapy designations. This role involves collaboration with cross-functional project teams in planning development strategies and leading global regulatory submissions within the Rallybio portfolio. Responsibilities Create and execute the global regulatory strategy for the product to achieve regulatory approval and product labeling objectives Generate global regulatory strategic roadmaps to support product development, registration, commercialization, and lifecycle manageme
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