Associate Director/Director, Regulatory Affairs

Axsome Therapeutics is a biopharmaceutical company seeking an Associate Director/Director, Regulatory Affairs to manage assigned regulatory activities for product candidates. The role involves interacting with regulatory agencies, preparing submissions, and providing regulatory guidance.

Requirements

• Bachelor’s degree required
• 7-10 years of relevant Regulatory Affairs experience
• Proficiency in FDA electronic gateway submissions
• Broad understanding of eCTD requirements
• 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

Benefits

• Annual bonus
• Significant equity
• Generous benefits package