Manager/Senior Manager, Regulatory Affairs Advertising and Promotion

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

About This Role  

Axsome Therapeutics is seeking a Manager/Senior Manager, Regulatory Affairs Advertising and Promotion who will be responsible for providing regulatory guidance on promotional and non-promotional communications to ensure compliance with FDA regulations and internal standards. This individual will work with Regulatory Advertising and Promotion leadership to support the strategic execution of the company’s promotional regulatory activities and collaborate closely with cross-functional partners, including Marketing, Medical Affairs, Legal, and Commercial Operations. This role will also supports the submission of materials to the FDA. This position reports to the Executive Director, Regulatory Affairs Advertising and Promotion. 

This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.  

Job Responsibilities and Duties include, but are not limited to, the following: 

• 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 both are compliant with relevant laws, regulations, guidance documents, and internal policies related to the proper use and safety of products
• Support the submission of promotional materials to FDA for post marketing requirements and advisory comment as needed
• Work with Ad/Promo leadership to monitor, interpre