Associate Director/Director, Regulatory Affairs Advertising ...

The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. About This Role Axsome Therapeutics is seeking an Associate Director/Director... Regulatory Affairs Advertising & Promotion to The Associate Director/Director, Regulatory Affairs Advertising & Promotion will help to establish and implement the promotional regulatory strategy for the company and will work with the Executive Director, Regulatory Affairs Advertising and Promotion to ensure professional and efficient interactions between the company and Office of Prescription Drug Promotion (OPDP). This role will report to the Executive Director, Regulatory Affairs Advertising and Promotion This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. Support the US Commercial teams, including relevant stakeholders, by participating in strategy discussions, labeling negotiations, and extended team meetings; provides regulatory guidance and perspective on marketing strategies and promotion objectives and tactics Identify and assist teams in overcoming barriers and finding solutions in achieving quality and compliance Proposes creative solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk Maintain a productive relationship with FDA to help ensure successful and timely review of advisory submissions and effective resolution of regulatory actions Provide training on advertising and promotion regulations to key stakeholders Identify areas of potential regulatory compliance vulnerability and risk; develop/collaborate on corrective measures Collaborate with other functions (e.g., Medical Affairs, Commercial) on policy and procedure development Independently communicates timing and strategy for revisions to promotional labeling and advertising based on planned or unplanned changes to product labeling, advisory comments, enforcement, or FDA guidance documents Independently develop documents related to use of product labeling in promotion and advertising, including but not limited to, policies, procedures, and safety-related claims (i.e., important safety information, brief summary, major statement) Requirements / Qualifications BS life sciences degree or equivalent required. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location.