Manager/Senior Manager, Regulatory CMC

Axsome Therapeutics•New York, NY

4d•Hybrid

About The Position

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.

Requirements

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
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

Responsibilities

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