Senior Director, Promotional Compliance & Launch Strategy

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

Ventajas ofrecidas por este puesto de trabajo

Comprehensive medical coverage

Tuition reimbursement

Generous 401(k) match

Descripción de la vacante

Otsuka America Pharmaceutical, Inc. seeks an experienced regulatory professional to direct and approve promotional labeling materials and communications for prescription drug products.

The role focuses on ensuring compliance with FDA advertising and promotion rules and supporting rare disease launch activities. The candidate will review claims, provide strategic regulatory guidance, and collaborate with Commercial, Medical, Legal, and Regulatory teams to drive compliant launch plans and

Formación

• 6+ years of experience in pharmaceutical advertising and promotion compliance

Responsabilidades

• Reviews promotional materials for regulatory compliance and strategic messaging
• Reviews and approves promotional labeling in line with regulations
• Partners with Commercial, Medical, Legal, and Regulatory teams on launch activities
• Maintains timely submission of materials to OPDP (FDA Form 2253)

Conocimientos

Regulatory strategy

FDA advertising rules

Cross-functional collaboration

Promotional review

Educación

Bachelor's degree

Advanced scientific/clinical degree

Herramientas

MS Office

Veeva PromoMats

CREDO

Outlook

Teams

Adobe Acrobat

Descripción del empleo

Otsuka America Pharmaceutical, Inc. seeks an experienced regulatory professional to direct and approve promotional labeling materials and communications for prescription drug products.

The role focuses on ensuring compliance with FDA advertising and promotion rules and supporting rare disease launch activities. The candidate will review claims, provide strategic regulatory guidance, and collaborate with Commercial, Medical, Legal, and Regulatory teams to drive compliant launch plans and