Senior Manager for Regulatory Affairs

Job 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.
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).

Qualifications

Requires a minimum of 5+ yrs of direct regulatory promotional and non-promotional material review experience.

Additional Information

All your information will be kept confidential according to EEO guidelines.