Manager/Senior Manager, Regulatory Affairs Advertising and Promotion

Axsome Therapeutics is seeking a Manager/Senior Manager, Regulatory Affairs Advertising and Promotion who will provide regulatory guidance on promotional and non-promotional communications to ensure compliance with FDA regulations and internal standards.

Requirements

• Serve as a core Regulatory reviewer on the Promotional Review Committee (PRC) for US advertising and promotional materials
• Independently review advertising and promotional labeling materials and internal communications to ensure compliance with relevant laws, regulations, guidance documents, and internal policies
• Support the submission of promotional materials to FDA for post marketing requirements and advisory comment as needed
• Propose creative solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk
• Identify areas of potential regulatory compliance vulnerability and risk; develop/collaborate on corrective measures

Benefits

• Annual bonus
• Significant equity
• Generous benefits package