Location: New York, NY
Manager (Sr.), Regulatory Affairs
Axsome Therapeutics is currently searching for a (Sr.) Manager, Regulatory Affairs to support our regulatory affairs efforts.
Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders.
The Axsome team is comprised of a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders.
Axsome is based in New York City, New York.
The role is responsible for supporting regulatory activities for the development and commercialization of Axsome’s product candidates. This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by the department head when needed. The Manager is responsible for mentoring associates as appropriate.
- Participate in regulatory agency interactions.
- Contribute to preparations for agency meetings, communications, and submissions.
- Support the development, writing, and review of regulatory submissions including NDA, MAA, IND, TGA, and CTA filings.
- Participate in regulatory strategy development and planning.
- Contribute to assessment of compliance risk areas (internal and external) and development and implementation of risk mitigation measures.
- 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.
- Perform other work-related duties as assigned.
- Bachelor degree required. Preference to candidates with a scientific background (RN, MS, PhD or similar).
- Five years of relevant experience preferred.
- Proficiency in FDA electronic gateway submissions.
- Broad understanding of eCTD requirements.
- Preference to candidates with prior small company experience.
- Preference to candidates with prior NDA and MAA filing experience.
- Preference to candidates with prior CNS experience.
- Knowledge of the 505(b)(2) regulatory strategy.
- Must be able to work in the NYC office.
- 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.
- Excellent sense of urgency to deliver at/surpass study conduct targets.
- 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.
- Preference to energetic candidates with a desire to think “outside the box.”
- Willingness to travel periodically as needed.