Associate Director​/Director, Regulatory Affairs

Associate Director/Director, Regulatory Affairs

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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 and follow us on Linked In and X.

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.

• 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

• Bachelor’s degree required. Preference for candidates with an scientific advanced scientific degree
• 7-10 years of relevant Regulatory Affairs experience
• Proficiency in FDA electronic gateway submissions
• Broad understanding of eCTD requirements
• Willingness to travel as needed
• Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles

• Prior NDA and MAA filing experience
• Prior CNS experience preferred but, not required
• Experience in translating regulatory strategy into actionable plans
• Established knowledge of regulatory guidelines and regulations (US and international)
• Regulatory experience supporting both development projects and marketed products preferred
• Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, is preferred
• Ability to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies lead to obtaining results
• Strong attention to detail and excellent organization skills
• Exceptional communication skills (written and verbal) as evidenced by a demonstrated ability to prepare complex documents and submissions and to give presentations
• Strong interpersonal skills
• Ability to problem solve, delegate appropriate tasks and/or develop junior team members
• Strong leadership skills, self‑motivated, adaptable to a dynamic environment
• Comfortable multi‑tasking in a fast‑paced small company environment and able to adjust workload based upon changing priorities

The anticipated salary…