Manager/Senior Manager, Regulatory CMC

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 Assists Regulatory CMC Team and CMC Team with 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. Routine attendance at critical CMC and CDMO meetings to ensure CMC‑REG topics are addressed. Monitors both 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. Stays current on CMC‑REG CDER guidance, 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, 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. #J-18808-Ljbffr Role, Inc.