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Senior Manager, Regulatory Affairs Jobs

Weston, Massachusetts
<p>Job Title:Senior Manager, Regulatory AffairsJob Location: Weston, MAJob Duration: 3 MonthsContractor, US Regulatory Affairs Advertising and PromotionUS Regulatory Advertising and Promotion (US Reg AD/Promo) is responsible for actively contributing to the implementation of regulatory strategy for promotional messaging. The contractor will serve as the regulatory representative on assigned review teams for promotional and non-promotional materials and contribute, as appropriate, to other assigned projects.Essential functions: Responsible for accuracy and content of communications with FDA Extensive knowledge of advertising and promotion regulations and ability to interpret regulations to promotional materials and non-promotional materials Ability to influence teams Actively contribute to the development and implementation of regulatory strategy for promotional materials as well as any other assigned projects and programs. Decision maker in review meetings Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects and programs. This includes promotional materials, including pre-use submissions for subpart E & H products. Provide regulatory guidance to cross-functional teams that establish strategy and vision for promotional materials, sales training materials, and other external communications. Work is performed under general direction. Capable of strategic thinking and risk assessment for area of responsibility. Demonstrate good communication skills (oral/written/listening).Requires a minimum of 8 yrs of direct regulatory promotional and non-promotional material review experience.</p>
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