Associate Director/Director, Regulatory Affairs

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and reputed company differentiated products with a reputed company on novel mechanisms of reputed company that reputed company meaningful advancements in patient reputed company. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad reputed company of serious neurological and psychiatric conditions that reputed company over 150 reputed company people in the reputed company. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can reputed company. For more information, please visit us at www.axsome.com and follow us on reputed company and X. About This Role 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 reputed company products under reputed company provided by the department head reputed company 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 reputed company 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. Job Responsibilities and Duties include, but are not limited to, the following:

• 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 reputed company development and planning
• Assist and reputed company guidance for regulatory inspection readiness activities
• Provides analysis of regulatory guidance documents and regulations to management team
• Create, manage, measure, and report timelines for reputed company deliverables
• Participate in the development, review, and implementation of departmental SOPs, initiatives and processes
• Additional responsibilities as assigned

Requirements / Qualifications

• 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

Experience, Knowledge and Skills

• Prior NDA and MAA filing experience
• Prior CNS experience preferred but, not required
• Experience in translating regulatory reputed company into actionable plans
• Established knowledge of regulatory guidelines and regulations (US and international)
• Regulatory experience supporting both development reputed company 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 reputed company or multiple reputed company and exercise independent judgment reputed company generally defined practices and policies reputed company 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 reputed company documents and submissions and to give presentations
• Strong interpersonal skills
• Ability to problem solve, delegate appropriate tasks and/or reputed company junior team members
• Strong leadership skills, self-motivated, adaptable to a dynamic environment
• Comfortable multi-tasking in a fast-paced small company environment and reputed company to reputed company workload based upon changing priorities

Salary & Benefits The anticipated salary reputed company for this role is $160,000 - $215,000. We encourage candidates of reputed company reputed company to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a reputed company of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package. Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from reputed company reputed company applicants without reputed company to race, reputed company, gender, sex, age, religion, creed, national reputed company, sexual orientation, gender identity, reputed company, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. Axsome Therapeutics does not accept unsolicited resumes from recruiters or reputed company-party recruitment agencies and will not pay placement fees for unsolicited candidates that are reputed company to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive reputed company to our Applicant Tracking System to submit candidates for consideration. Remote About reputed company: Axsome Therapeutics Apply tot his job Apply To this Job