Regulatory Advertising Lead for Rare Disease Launch(Remote)

Otsuka America Pharmaceutical Inc.; San Juan (PR); Remote; USD 186,000 - 279,000; Full time

Benefits offered by this job

Medical benefits

401(k) match

Paid holidays

Paid leave programs

Job summary

Otsuka America Pharmaceutical, Inc. in Princeton, NJ, is seeking a Senior Regulatory Compliance Director to lead and review promotional labeling and communications for prescription drugs and medical devices.

You will provide strategic regulatory guidance, work with Commercial, Medical, Legal, and Regulatory teams, ensure FDA Form 2253 submissions, and stay current on OPDP requirements. This role emphasizes cross-functional partnering and rigorous compliance in a fast-paced launch environment.

Qualifications

• 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotechnology or pharmaceutical industry
• Experience leading or supporting pharmaceutical product launches, including pre-launch planning, launch readiness, and commercialization activities
• Experience supporting rare disease products
• Demonstrated ability to provide practical, risk-based regulatory guidance in cross-functional commercial environments
• Demonstrated ability to balance regulatory risk and business objectives in a fast-paced launch environment
• Solid understanding of U.S. regulatory requirements
• Excellent understanding of medical concepts and terminology
• Strong understanding of FDA advertising and promotion requirements and applicable product labeling
• Fundamental understanding of the pharmaceutical industry drug development process

Responsibilities

• Ensures promotional materials and communications are compliant with applicable laws, regulations, and company requirements.
• Reviews and approves promotional materials and provides strategic guidance on promotional messaging.
• Provides strategic regulatory guidance during pre-launch and launch activities, including review of promotional claims, scientific communications, disease state education materials, and disease awareness initiatives.
• Reviews promotional materials and communications to ensure consistency with approved product labeling, regulatory requirements, and audience use.

Skills

Promotional compliance

Regulatory strategy

OPDP knowledge

Launch readiness

Cross-functional collaboration

FDA advertising

Education

Bachelor’s Degree

PharmD/PhD/MS preferred

Tools

MS Office

Veeva PromoMats

CREDO

Outlook

Teams

Adobe Acrobat

Job description

Otsuka America Pharmaceutical, Inc. in Princeton, NJ, is seeking a Senior Regulatory Compliance Director to lead and review promotional labeling and communications for prescription drugs and medical devices.

You will provide strategic regulatory guidance, work with Commercial, Medical, Legal, and Regulatory teams, ensure FDA Form 2253 submissions, and stay current on OPDP requirements. This role emphasizes cross-functional partnering and rigorous compliance in a fast-paced launch environment.