Manager, Regulatory CMC

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.

About This Role:

Axsome Therapeutics is seeking a 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:

• Assist 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
• Assist Regulatory CMC Team with the following: Routinely attend the critical CMC and CDMO meetings to ensure CMC-REG topics are addressed
• Monitor both the USP and EP for proposed changes to APIs, excipients, test methods, and general policies ensuring the Axsome drugs are not adversely impacted
• Track and archive submissions, correspondences, and commitments with health authorities
• Remain current on CMC-REG CDER guidance’s, MAPPS, and ICH Guidelines
• Interact with CMC vendors in support of CMC and Regulatory CMC teams
• Participate 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; bachelor’s degree in a life science, with at least 5 years of Regulatory CMC experience may be considered
• 1– 3 years of relevant Regulatory CMC experience in the Biotechnology or Pharmaceutical industry
• Experience with solid oral dosage forms
• Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles

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 $95,000 - $120,000. 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.