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| Associate Director IL Open (J#28531) Title: Associate Director Company: Takeda Pharmaceuticals North Description OBJECTIVES: - Provide regulatory strategic direction for one or more products during development (pre-FDA approval) as needed and follow FDA approval (marketed products). - Responsible for all regulatory aspects of multi-disciplinary or multi-faceted marketing programs (i.e., multiple indications for a given compound). - Supervises, trains, and provides technical and regulatory guidance to staff. - Represents the company at regulatory meetings. - Interacts with all levels of staff at the DDMAC divisional level of FDA. ACCOUNTABILITIES: - Provides strategic direction for the development and implementation of regulatory promotional strategies for products of responsibility. - Plans, executes and manages regulatory DDMAC submissions for assigned compounds. - Provides oversight to ensure regulatory compliance of promotional materials generated for assigned compounds. - Provides strategic direction for DDMAC meeting preparations. - Negotiates regulatory issues with DDMAC. - Provides product development strategy and label development strategy as needed to ensure claims can be supported. - Evaluates regulatory risks and makes recommendations relative to the overall MRL strategy. - Manages others DDMAC regulatory professionals as assigned. - Sets direction for the review of competitive materials and interactions with FDA to urge enforcement activity as necessary. - Other duties as assigned. Requirements More... | |||
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