Associate Director/Director, Regulatory Affairs
About The Position
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.
Requirements
- 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
Nice To Haves
- 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
Responsibilities
- 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
Benefits
- Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.
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What This Job Offers
Job Type
Full-time
Career Level
Director
