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Regulatory Affairs Consultant
Ref No.: 18-00144
Location: Remote
Position Type:Contract
Experience Level: 5 Years
Start Date: 01/25/2018
Description:
  • US 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.
Responsibilities:
  • 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).