Associate Director/Director, Regulatory Affairs jobs in United States
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Axsome Therapeutics, Inc. · 1 month ago

Associate Director/Director, Regulatory Affairs

positionNew York, NY
timeFull-time
remoteOnsite
senioritySenior Level, Lead/Staff, Director/Executive
money$160K/yr - $215K/yr
date7+ years exp

Axsome Therapeutics is a biopharmaceutical company focused on treating CNS conditions. The Associate Director/Director, Regulatory Affairs will manage regulatory activities for product candidates and mentor associates, ensuring compliance and strategic development in regulatory submissions.

BiopharmaBiotechnologyTherapeutics

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

Qualification

Regulatory Affairs experienceFDA electronic submissionsNDAMAA filingECTD requirementsRegulatory guidelines knowledgeCNS experienceClinical research operationsCommunication skillsLeadership skillsProblem-solving skills

Required

Bachelor's degree required
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

Preferred

Preference for candidates with an scientific advanced scientific degree
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

Benefits

Annual bonus
Significant equity
Generous benefits package

Company

Axsome Therapeutics, Inc.

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Axsome Therapeutics, Inc.
dateFounded in 2012
location
New York, New York, USA
people-size201-500 employees
web-link
http://axsome.com

Funding

Current Stage
Public Company
Total Funding
$1B
2025-05-13Post Ipo Debt· $570M
2023-06-28Post Ipo Equity· $225M
2019-12-23Post Ipo Equity· $200M

Leadership Team

H
Herriot Tabuteau
Chief Executive Officer
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Recent News

Investing.com
Top US Biopharma Stocks Poised for Growth in 2026, According to Deutsche Bank
2026-01-22
Clinical Trials Arena
Axsome begins Phase III AXS-14 FORWARD trial for fibromyalgia management
2026-01-17
GlobeNewswire
Axsome Therapeutics Initiates FORWARD Phase 3 Trial of AXS-14 for the Management of Fibromyalgia
2026-01-16
Company data provided by crunchbase