The ideal candidate will have a deep understanding of the regulatory landscape, a proven track record of working with cross-functional teams, and the ability to communicate regulatory risks and strategies to company leadership. – – Regulatory Strategy & Oversight: Lead the regulatory review as a member of the MLR review team of advertising and promotional materials for compliance with FDA, FTC, and other applicable U.S. regulations, guidelines, and internal company standards and policies. – – Training & Education: Provide regulatory training and guidance to internal stakeholders to ensure a consistent understanding of regulatory advertising and promotion requirements. – – Strong understanding of FDA regulations, particularly with respect to the advertising and promotion of prescription drugs, biologics, or medical devices in the U.S. – – Experience in both the pharmaceutical/biopharmaceutical and medical device sectors is a plus.
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