Associate/Sr. Associate, Regulatory Operations

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 an Associate/Sr. Associate, Regulatory Operations. The role is responsible for managing regulatory operations necessary to ensure the successful preparation and filing of regulatory submissions for Axsome’s product candidates.

This is a hybrid role based at Axsome’s HQ in New York City.

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

• Coordinate publishing activities for eCTD submissions including ensuring regulatory documents are submission ready, transferring final documents for publishing, completing QC of published output, and confirming submission to the health authority
• Maintain electronic document management system and RIM systems for the Regulatory Department
• Track and archive submissions, correspondences, and commitments with health authorities
• Interact with vendors in support of electronic publishing and other aspects of regulatory operations
• Assist with authoring, tracking, and maintaining ClinicalTrials.gov in accordance with 42 CFR Part 11 guidelines
• Review essential regulatory documents for drug shipment authorization to clinical study sites
• Participate in the development, review, and implementation of departmental SOPs, initiatives and processes

Requirements / Qualifications

• Bachelors Degree required
• 1-3 years of relevant Regulatory Affairs/Regulatory Operations experience
• Understanding of the regulatory requirements for electronic submissions and have had prior experience with regulatory document publishing
• Demonstrated experience with electronic document management / regulatory information management (RIM) systems, as well as maintaining online clinical trial registries
• Ability to work on site Monday, Tuesday & Thursday

Experience and Knowledge

• Understanding of eCTD requirements, FDA electronic gateway submissions, and FDA guidance documents
• Operational experience supporting investigational and/or marketed products (INDs/CTAs, NDAs/MAAs)
• Prior experience with regulatory document publishing and submission, preferred
• Prior experience with RIM systems, preferred
• Prior experience with ClinicalTrials.gov, preferred
• 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 and Benefits:

The anticipated salary range for this role is $75,000 - $85,000. 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.