Associate Director, Regulatory Affairs – Advertising and Promotion

ResponsibilitiesReview and approval of all US promotional materialsServe as the promotional regulatory expert with legal, medical and commercial colleaguesEnsure promotional practices are consistent with regulatory guidelines, company policies, and support business objectivesManage correspondence with FDA’s promotional review divisions OPDP/APLBPropose creative, effective, and compliant regulatory strategies and solutionsProvide regulatory consultation in the development and implementation of US marketing strategy and promotional programsSupport commercial teams by providing regulatory guidance on marketing strategiesParticipate in labeling and global regulatory team meetingsMaintain current awareness of FDA advisory correspondence and regulationsProvide promotional regulatory training and coaching to team membersContribute to departmental strategic initiativesRequirementsB.A. or B.S. degree with an emphasis in science, health care or related fieldsMinimum of five years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory or scientific disciplinesMinimum of two years of direct experience as the primary regulatory reviewer of advertising and promotional materialsDemonstrated knowledge of FDA regulations relating to advertising and promotion for prescription productsProactive with strong cross-functional collaboration skillsDemonstrated history of successful interactions with the promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launchUnderstanding of the product development and labeling processExcellent verbal and written communication skillsAttention to detail and ability to manage multiple priorities simultaneouslyStrong interpersonal skills with ability to demonstrate strategic and analytical thinkingDemonstrated ability to negotiate and influence others effectively#J-18808-Ljbffr

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