Director, Promotional Compliance & Launch Strategy

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

Benefits offered by this job

Company benefits

Job summary

Otsuka America Pharmaceutical Inc. is seeking a seasoned regulatory compliance professional in Princeton, NJ (Remote).

The role focuses on directing or assisting staff to review and approve promotional labeling materials and communications for prescription drug and medical device products, ensuring compliance with regulatory requirements. The candidate will partner with Commercial, Medical, Legal, and Regulatory teams, guiding pre-launch and launch activities, and enforcing timely submission of

Qualifications

• 6+ years of experience in pharmaceutical advertising and promotion compliance.
• 1+ year leading or supporting launches.
• Experience supporting rare disease products.
• Ability to provide practical, risk-based regulatory guidance in cross-functional commercial environments.
• Balance regulatory risk and business objectives in a fast-paced launch environment.
• Solid understanding of U.S. regulatory requirements.
• Strong understanding of medical concepts and terminology.
• Strong understanding of FDA advertising and promotion requirements.

Responsibilities

• Ensure promotional materials comply with laws and company requirements.
• Review and approve promotional materials with strategic messaging insights.
• Provide strategic regulatory guidance during pre-launch and launch activities.
• Ensure consistency of materials with approved labeling and regulatory requirements.
• Partner with Commercial, Medical, Legal, and Regulatory teams for launch activities.
• Review and approve promotional materials, sales training, and corporate communications.
• Support materials related to complex diseases, including diagnostic considerations.

Skills

Regulatory compliance

Advertising & promotion

Cross-functional collaboration

Regulatory strategy

Regulatory guidance

FDA advertising rules

Communication skills

Education

Bachelor’s Degree

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

Tools

MS Office

Veeva PromoMats

CREDO

Outlook

Teams

Adobe Acrobat

Job description

Otsuka America Pharmaceutical Inc. is seeking a seasoned regulatory compliance professional in Princeton, NJ (Remote).

The role focuses on directing or assisting staff to review and approve promotional labeling materials and communications for prescription drug and medical device products, ensuring compliance with regulatory requirements. The candidate will partner with Commercial, Medical, Legal, and Regulatory teams, guiding pre-launch and launch activities, and enforcing timely submission of