Manager/Senior Manager, Regulatory CMC

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 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. This role will also serve as a resource to the CMC team members for the regulatory 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.

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

• Assists Regulatory CMC Team and CMC Team with the following: drafting Module 2 and Module 3 documents; acquiring supportive documentation (Letters of Authorization, Certificates of Analysis, Batch Records, etc.); 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.

• Tracks and archives submissions, correspondences, and commitments with health authorities

• Remains current on CMC-REG CDER guidance’s, MAPPS, and ICH Guidelines

• Interacts with CMC vendors in support of CMC and Regulatory CMC teams

• Participates in the development, review, and implementation of departmental SOPs, initiatives and processes

Requirements / Qualifications

• Master’s or Ph.D. degree in chemistry or associated science preferred with 1– 3 years of relevant Regulatory CMC experience in the Biotechnology or Pharmaceutical industry

• Bachelor’s degree in a life science with at least 5 years of Regulatory CMC experience may be considered

• Experience with solid oral dosage forms

Experience and Knowledge

• Understanding of eCTD requirements, 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 & Benefits

The anticipated salary range for this role is $115,000 - $145,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.

Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.