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. com and follow us on LinkedIn and X .

About This Role

: Axsome Therapeutics is seeking a Manager/Senior Manager, Regulatory CMC. This role provides regulatory Chemistry Manufacturing Controls (CMC) support for assigned corporate development and commercial programs and is responsible for the regulatory aspects of the CMC for small molecules. The Manager, Regulatory CMC with supervision, participates in CMC regulatory activities necessary to conduct clinical trials and achieve marketing approval of drug candidates.

This position will represent the regulatory function on multi-disciplinary CMC product development teams with external entities, as needed.

Requirements

, processes, and logistics to conduct drug development activities for compounds for clinical stage and commercial products. The role will report to the Executive Director, Regulatory CMC. 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.

, FDA electronic gateway submissions, CDER guidance’s, CDER MAPPS, ICH guidelines, USP, and EP Regulatory CMC experience supporting investigational and/or marketed products (INDs/CTAs, NDAs/MAAs) Proficiency with Microsoft Office Suite and Adobe Acrobat Ability to learn new software packages and electronic systems Strong attention to detail and excellent organization skills Exceptional time-management skills Strong interpersonal skills Salary

Responsibilities

); and entering data into draft Module 3 documents. Assists Regulatory CMC Team with the following: Routinely attends the critical CMC and CDMO meetings to ensure CMC-REG topics are addressed. Monitors both the USP and EP for proposed changes to APIs, excipients, test methods, and general policies ensuring the Axsome drugs are not adversely impacted.

Qualifications

Benefits

The anticipated salary range for this role is $ 115,000 - $145,000 .