Remote Director of Advertising & Promotion Compliance

Otsuka America Pharmaceutical Inc.; Phoenix (AZ); A distancia; USD 186.000 - 279.000; Jornada completa

Descripción de la vacante

Otsuka America Pharmaceutical Inc. is seeking an experienced regulatory professional to oversee promotional labeling materials and communications for prescription drugs and medical devices.

The role involves strategic regulatory guidance, cross-functional collaboration, and ensuring all materials meet regulatory and internal standards. The ideal candidate has a strong understanding of FDA advertising and promotion, experience with launches, and the ability to partner with Commercial, Medical,

Formación

• 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotechnology or pharmaceutical industry
• Experience leading or supporting pharmaceutical product launches, including pre-launch planning, launch readiness, and commercialization activities
• Experience supporting rare disease products
• Demonstrated ability to provide practical, risk-based regulatory guidance in cross-functional commercial environments
• Demonstrated ability to balance regulatory risk and business objectives in a fast-paced launch environment
• Solid understanding of U.S. regulatory requirements
• Excellent understanding of medical concepts and terminology
• Strong understanding of FDA advertising and promotion requirements and applicable product labeling
• Fundamental understanding of the pharmaceutical industry drug development process

Responsabilidades

• Ensures promotional materials and communications are compliant with applicable laws, regulations, and company requirements.
• Analyzes and interprets new regulations and Guidance to Industry documents, and monitors the impact of 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 and disease state education materials.
• Reviews promotional materials to ensure consistency with approved labeling and regulatory requirements.
• Partners cross-functionally with Commercial, Medical, Legal, and Regulatory teams to support launch activities and promotional strategy.
• Supports review of materials related to complex or highly specialized disease states and diagnostic considerations.
• Ensures materials are submitted to OPDP on FDA Form 2253 and archived per policy.
• Monitors changes in U.S. promotional regulations and incorporates changes into processes.
• Participates in cross-functional meetings like Global Regulatory Team and Global Labeling Team.
• Participates in launch planning and cross-functional discussions for pipeline and commercialization activities.
• Provides training on promotional compliance regulations to internal employees and affiliates.
• Acts as liaison between the company and OPDP and supports regulatory discussions on promotional strategy.

Conocimientos

Regulatory compliance

FDA advertising

Cross-functional collaboration

Promotional labeling

Training materials

Educación

Bachelor’s Degree in a scientific field

Advanced scientific or clinical degree (PharmD, PhD, MS) preferred

Herramientas

MS Office

Veeva PromoMats

CREDO

Outlook

Teams

Adobe Acrobat

Descripción del empleo

Otsuka America Pharmaceutical Inc. is seeking an experienced regulatory professional to oversee promotional labeling materials and communications for prescription drugs and medical devices.

The role involves strategic regulatory guidance, cross-functional collaboration, and ensuring all materials meet regulatory and internal standards. The ideal candidate has a strong understanding of FDA advertising and promotion, experience with launches, and the ability to partner with Commercial, Medical,