The Associate Director RA serves as the regulatory lead on Review Committees (RCs) As the RC RA representative, work with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations, company policies, and applicable Industry Guidelines for the advertising and promotion of prescription drugs, biologics, and devices ... Provide regulatory leadership and guidance to Commercial teams during the development, review and approval of product labeling and advertising materials. Work collaboratively with medical and scientific personnel on the development and review of materials related to advertising and promotion. Must be confident in their analysis and application to impacted materials to ensure compliance with the regulations. At least five (5) years of experience involving the direct implementation of promotional labeling and advertising regulations in the biotech/pharmaceutical/medical device industry; this must include extensive experience providing regulatory input and evaluation as part of a promotional review committee.
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