Job Overview The US Advertising and Promotion Regulatory Expert will be responsible for providing expert guidance on FDA regulations, guidance and enforcement trends governing the promotion of prescription drug and biologic products. You will contribute to Takeda's mission by ensuring regulatory compliance of promotional materials generated for assigned US products and/or compounds. About You This role requires a minimum of 5 years' experience in drug, biologic and/or device Regulatory Affairs or related field, including a minimum of 3 years' experience specific to Regulatory Affairs - Advertising and Promotion. You should have knowledge of applicable regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biologic products for healthcare professionals, payor and consumer audiences. Your Responsibilities You will interpret complex issues in relation to regulatory requirements and promotional strategy, provide regulatory strategic oversight for at least one (1) complex product or therapeutic area/multiple products, mentor and develop staff, supervise, train and provide technical and regulatory guidance to staff.
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