Director, Advertising and Promotion

Analyzes and interprets new regulations and Guidance to Industry documents, and monitors the impact of Office of Prescription Drug Promotion (OPDP) correspondence and enforcement actions.Reviews and approves promotional materials and provides strategic guidance on promotional messaging.Provides strategic regulatory guidance during pre-launch and launch activities, including review of promotional claims, scientific communications, disease state education materials, and disease awareness initiatives.Reviews promotional materials and communications to ensure consistency with approved product labeling, regulatory requirements, and appropriateness for the intended audience and use.Partners cross-functionally with Commercial, Medical, Legal, and Regulatory teams to support launch activities and promotional strategy.Responsible for final review and approval of promotional materials, sales training materials, and corporate communications.Supports review of materials related to complex or highly specialized disease states, including diagnostic or testing considerations, patient identification, and disease education.Ensures product promotional materials are submitted to OPDP on FDA Form 2253 in a timely manner and archived as per company policy.Monitors changes in U.S. promotional regulations and corporate policies and procedures, and incorporates those changes into departmental processes, as appropriate.Participates in cross-functional meetings and teams, including the Global Regulatory Team (GRT) and Global Labeling Team (GLT).Participates in launch planning and cross-functional discussions for pipeline and commercialization activities.Provides training to internal employees and affiliates on promotional compliance regulations, as appropriate.Acts as a liaison between the company and OPDP and supports regulatory discussions related to promotional strategy, as appropriate.Required Qualifications 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotechnology or pharmaceutical industryExperience leading or supporting pharmaceutical product launches, including pre-launch planning, launch readiness, and commercialization activitiesExperience supporting rare disease productsDemonstrated ability to provide practical, risk-based regulatory guidance in cross-functional commercial environmentsDemonstrated ability to balance regulatory risk and business objectives in a fast-paced launch environmentSolid understanding of U.S. regulatory requirementsExcellent understanding of medical concepts and terminologyStrong understanding of FDA advertising and promotion requirements and applicable product labelingFundamental understanding of the pharmaceutical industry drug development processPreferred Qualifications Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Otsuka is an equal opportunity employer. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability.