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Global Regulatory Submissions Lead (Cambridge)

Full-time

Merida Biosciences

Merida Biosciences in Cambridge, MA is seeking an Associate Director of Regulatory Operations to lead global submission planning and lifecycle management across development programs.

This hands-on role drives document readiness, eCTD publishing, cross-functional coordination with regulatory affairs, and strategic execution to ensure timely, compliant submissions while enabling efficient regulatory operations.

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Vacancy posted 12 hours ago
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