Senior Director, Regulatory Advertising and Rare Disease Launch

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

Descripción de la vacante

Otsuka America Pharmaceutical, Inc. in Princeton, NJ is seeking a senior regulatory professional to direct or assist staff in reviewing and approving promotional labeling and communications for prescription drugs and medical devices.

The role requires ensuring materials meet regulatory and company requirements and serving as a strategic regulatory partner for rare disease launches. The candidate will lead cross-functional teams, review promotional claims, and provide guidance during pre-launch

Formación

• 6+ years of experience in pharmaceutical advertising and promotion compliance
• Experience launching or supporting pharmaceutical products
• Experience with rare disease products
• Regulatory guidance in cross-functional commercial environments
• Balance regulatory risk with business objectives in launch environments
• Strong understanding of U.S. regulatory requirements
• Strong knowledge of FDA advertising and promotion requirements
• Understanding of drug development process

Responsabilidades

• Ensure promotional materials comply with laws, regulations and company requirements
• Analyze new regulations and monitor OPDP actions
• Review and approve promotional materials and provide strategic guidance
• Provide regulatory guidance during pre-launch and launch activities
• Ensure consistency with product labeling and regulatory requirements
• Collaborate cross-functionally to support launch activities
• Finalize review and approval of promotional materials and training materials
• Support materials related to complex disease states and diagnostics
• Submit promotional materials to OPDP on FDA Form 2253
• Monitor changes in U.S. regulatory regulations and update processes
• Participate in cross-functional meetings (GRT, GLT)
• Participate in launch planning and cross-functional discussions
• Provide training on promotional compliance regulations
• Act as liaison with OPDP and support regulatory discussions

Conocimientos

Pharma advertising compliance

Regulatory strategy

Launch planning

Cross-functional collaboration

FDA labeling & promotion

Regulatory risk assessment

Regulatory communications

Educación

Bachelor's degree

Advanced scientific/clinical degree (PharmD/PhD/MS)

Herramientas

MS Office

Veeva PromoMats

CREDO

Outlook

Teams

Adobe Acrobat

Descripción del empleo

Otsuka America Pharmaceutical, Inc. in Princeton, NJ is seeking a senior regulatory professional to direct or assist staff in reviewing and approving promotional labeling and communications for prescription drugs and medical devices.

The role requires ensuring materials meet regulatory and company requirements and serving as a strategic regulatory partner for rare disease launches. The candidate will lead cross-functional teams, review promotional claims, and provide guidance during pre-launch