Associate Director/Director, Regulatory Affairs

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 an Associate Director/Director, Regulatory Affairs. The role is responsible for managing assigned regulatory activities for the development and commercialization of Axsome’s product candidates. The right candidate will have had prior experience in independently providing regulatory guidance to investigational and commercial products under oversight provided by the department head when needed. The Associate Director/Director is responsible for mentoring associates as appropriate. This role reports directly to the VP, Regulatory Affairs.

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:

• Participate in regulatory agency interactions
• Manage preparations for agency meetings, communications, and submissions
• Author and review regulatory submissions including IND, NDA, and ex-US filings
• Contribute to regulatory strategy development and planning
• Assist and provide guidance for regulatory inspection readiness activities
• Provides analysis of regulatory guidance documents and regulations to management team
• Create, manage, measure, and report timelines for milestone deliverables
• Participate in the development, review, and implementation of departmental SOPs, initiatives and processes
• Additional responsibilities as assigned

Requirements / Qualifications

• Bachelor’s degree required. Preference for candidates with an scientific advanced scientific degree
• 7-10 years of relevant Regulatory Affairs experience
• Proficiency in FDA elec