Director, Advertising and Promotion (Pharmaceutical Regulatory Compliance)

Location: Princeton, New Jersey, United States

Salary: $186,489–$278,875 annually, plus incentive opportunity

Company

Otsuka Pharmaceutical Companies develops and commercializes pharmaceutical products, including therapies for rare and specialized diseases.

What you will do

• Direct or support staff and independently review and approve promotional labeling, communications, sales training materials, and corporate communications.
• Provide strategic regulatory guidance for pre-launch, launch readiness, commercialization, and promotional strategy.
• Review promotional claims, scientific communications, disease-state education, disease-awareness initiatives, and materials for specialized disease states.
• Ensure materials are consistent with approved product labeling, applicable laws, FDA requirements, and company policies.
• Submit promotional materials to OPDP using FDA Form 2253 and maintain required archives.
• Partner with Commercial, Medical, Legal, Regulatory, Global Regulatory, and Global Labeling teams; provide training and support regulatory discussions with OPDP.

Requirements

• Must work in Princeton, New Jersey, United States.
• 6+ years of pharmaceutical advertising and promotion compliance experience in the biotechnology or pharmaceutical industry.
• Experience supporting pharmaceutical product launches, including pre-launch planning, launch readiness, and commercialization.
• Experience supporting rare disease products and providing practical, risk-based regulatory guidance.
• Strong knowledge of U.S. regulatory requirements, FDA advertising and promotion rules, product labeling, medical concepts, and pharmaceutical drug development.
• Bachelor’s degree required; an advanced scientific or clinical degree such as PharmD, PhD, or MS is preferred.

Nice to have

• 8+ years of pharmaceutical advertising and promotion compliance experience.
• Experience in neurology or other specialty therapeutic areas, with OPDP interactions, investigational products, or accelerated approval products.
• Experience leading, mentoring, or developing promotion compliance team members.
• Experience with Veeva PromoMats, CREDO, Microsoft Office, Outlook, Teams, and Adobe Acrobat.

Culture & Benefits

• Cross-functional environment focused on strategic thinking, accountability, patient and customer centricity, and respectful collaboration.
• Comprehensive medical, dental, vision, prescription drug, life, disability, and other insurance coverage.
• Tuition reimbursement, student loan assistance, and a generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.