Director, Regulatory Advertising & Promotion

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

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Life insurance

Disability insurance

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Paid leave

Job summary

Otsuka America Pharmaceutical, Inc. seeks a regulatory affairs professional to direct promotional labeling reviews for prescription drugs and devices.

You will ensure compliance with laws, guiding promotional messaging and clinical communications while supporting rare disease launches. The role demands cross-functional collaboration, strong regulatory knowledge, and experience leading pre-launch and launch activities.

Qualifications

• 6+ years of experience in pharmaceutical advertising and promotion compliance.
• Experience leading or supporting pharmaceutical product launches.
• Experience supporting rare disease products.
• Strong ability to provide practical, risk-based regulatory guidance.
• Solid understanding of U.S. regulatory requirements.
• Excellent understanding of medical concepts and terminology.
• Strong understanding of FDA advertising and promotion requirements.
• Fundamental understanding of the pharmaceutical drug development process.

Responsibilities

• Directs or assists staff and reviews promotional labeling materials for prescription drug and medical device products.
• Reviews and approves promotional materials and provides strategic guidance on messaging.
• Supports launch activities with cross-functional teams (Commercial, Medical, Legal, Regulatory).
• Ensures timely submission of materials to OPDP and archiving per policy.
• Participates in Global Regulatory and Labeling Team meetings and cross-functional launch planning.

Skills

Regulatory compliance

Cross-functional collaboration

FDA advertising knowledge

Education

Bachelor’s Degree

Advanced scientific/clinical degree

Tools

MS Office

Veeva PromoMats

Credo

Outlook

Job description

Otsuka America Pharmaceutical, Inc. seeks a regulatory affairs professional to direct promotional labeling reviews for prescription drugs and devices.

You will ensure compliance with laws, guiding promotional messaging and clinical communications while supporting rare disease launches. The role demands cross-functional collaboration, strong regulatory knowledge, and experience leading pre-launch and launch activities.