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 Operations.  Level will be commensurate with prior Regulatory Operations experience. The role is responsible for managing regulatory operations necessary to ensure the successful preparation and filing of regulatory submissions for multiple product candidates. The right candidate will have knowledge of the regulatory requirements for electronic submissions and prior experience with publishing of regulatory submission, electronic document management, and regulatory information management (RIM) systems. This role reports to the Executive Director, 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

• Publish electronic submissions: compile and generate submission packages, validate submission, and address any warnings or errors before submission
• Coordinate internal publishing activities
• Finalize regulatory documents for electronic submission by verifying document completeness and applying formatting standards
• Provide training and support for publishing and electronic document management systems
• Track submission statuses and maintain logs of submission sequences, dates, and acknowledgments
• Archive health authority communications and submissions, including storing published packages and validation reports
• Work closely with document authors, reviewers, and regulatory leads to ensure timely and high quality submission
• Manage vendors in support of electronic publishing and other aspects of regulatory operations
• Additional responsibilities as assigned

QUALIFICATIONS

• Bachelor’s degree required
• 5 years or more of Regulatory Operations experience
• Understanding of eCTD requirements, FDA electronic gateway submissions, and FDA guidance documents
• Operational experience supporting investigational and/or marketed products (INDs/CTAs, NDAs/MAAs)
• Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles

Experience, Knowledge and Skills

• Prior experience with regulatory document publishing and submission
• Prior experience with regulatory information management systems
• Proficiency with Microsoft Office Suite and Adobe Acrobat
• Strong attention to detail and excellent organization skills
• Exceptional time-management skills
• Strong interpersonal skills
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities

Salary and Benefits:

The anticipated salary range for this role is $120,000 - $150,000. 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.

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 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

Experience, Knowledge and Skills

• 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

Salary & Benefits

The anticipated salary range for this role is $160,000 - $215,000. 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.