Remote Director of Regulatory Advertising & Promotion

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

Benefits offered by this job

Comprehensive benefits

401(k) match

Paid holidays

Tuition reimbursement

Paid time off

Job summary

Otsuka America Pharmaceutical, Inc. seeks a regulatory professional to lead or support advertising and promotion compliance for prescription drug and medical device products.

The role reviews and approves promotional materials, guides pre-launch and launch activity, and partners with Commercial, Medical, Legal, and Regulatory teams. Responsibilities include ensuring alignment with labeling, monitoring OPDP actions, and providing training on regulatory requirements across initiatives.

Qualifications

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

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 appropriateness for the intended audience and use.
• Partners cross-functionally with Commercial, Medical, Legal, and Regulatory teams to support launch activities and promotional strategy.
• Responsible for final review and approval of promotional materials, sales training materials, and corporate communications.
• Supports review of materials related to complex or highly specialized disease states, including diagnostic or testing considerations, patient identification, and disease education.
• Ensures product promotional materials are submitted to OPDP on FDA Form 2253 in a timely manner and archived as per company policy.
• Monitors changes in U.S. promotional regulations and corporate policies and procedures and incorporates those changes into departmental processes, as appropriate.
• Participates in cross-functional meetings and teams, including the Global Regulatory Team (GRT) and Global Labeling Team (GLT).
• Participates in launch planning and cross-functional discussions for pipeline and commercialization activities.
• Provides training to internal employees and affiliates on promotional compliance regulations, as appropriate.
• Acts as a liaison between the company and OPDP and supports regulatory discussions related to promotional strategy, as appropriate.

Skills

Regulatory compliance

Cross-functional collaboration

Strategic regulatory guidance

FDA advertising & promotion

Launch planning

Communication skills

Education

Bachelor’s Degree; advanced degree preferred

Tools

MS Office

Veeva PromoMats

PowerPoint

Outlook

Adobe Acrobat

CREDO

Job description

Otsuka America Pharmaceutical, Inc. seeks a regulatory professional to lead or support advertising and promotion compliance for prescription drug and medical device products.

The role reviews and approves promotional materials, guides pre-launch and launch activity, and partners with Commercial, Medical, Legal, and Regulatory teams. Responsibilities include ensuring alignment with labeling, monitoring OPDP actions, and providing training on regulatory requirements across initiatives.