Director, Rare Disease Promo & Regulatory Strategy

Otsuka America Pharmaceutical Inc.; Denver (CO); Remote; USD 186,000 - 279,000; Full time

Job summary

Otsuka America Pharmaceutical, Inc. is seeking a Regulatory Director to lead promotional labeling reviews for prescription drug and medical device products.

The role focuses on ensuring all promotional materials meet regulatory requirements and providing strategic guidance during pre-launch and launch activities. The position requires extensive experience in pharmaceutical advertising compliance, strong understanding of U.S.

Qualifications

• 6+ years of experience in pharmaceutical advertising and promotion compliance.
• Experience supporting rare disease products.
• Strong understanding of U.S. regulatory requirements.
• Excellent understanding of medical concepts and terminology.

Responsibilities

• Ensure promotional materials comply with laws, regulations, and company requirements; monitor regulatory guidance.
• Review and approve promotional materials and provide strategic messaging guidance.
• Provide regulatory guidance during pre-launch and launch activities for promotional claims and education materials.
• Collaborate cross-functionally with Commercial, Medical, Legal, and Regulatory teams to support launch activities.

Skills

Regulatory compliance

FDA advertising

Cross-functional collaboration

Strategic guidance

Launch readiness

Regulatory reviews

Education

Bachelor’s Degree

Advanced scientific or clinical degree

Tools

Veeva PromoMats

CREDO

MS Office

Outlook

Teams

Job description

Otsuka America Pharmaceutical, Inc. is seeking a Regulatory Director to lead promotional labeling reviews for prescription drug and medical device products.

The role focuses on ensuring all promotional materials meet regulatory requirements and providing strategic guidance during pre-launch and launch activities. The position requires extensive experience in pharmaceutical advertising compliance, strong understanding of U.S.