Associate Director/Director, Regulatory Affairs

Axsome Therapeutics is seeking an Associate Director/Director, Regulatory Affairs to manage assigned regulatory activities for the development and commercialization of Axsome's product candidates. The role requires prior experience in independently providing regulatory guidance to investigational and commercial products. The Associate Director/Director is responsible for mentoring associates and reports directly to the VP, Regulatory Affairs.

Requirements

• 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

Benefits

• Annual bonus
• Significant equity
• Generous benefits package