Regulatory Promotions Lead – Rare Disease Launch

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

Benefits offered by this job

Comprehensive medical, dental, vision,

401(k) match

Flexible time off

Job summary

Otsuka America Pharmaceutical, Inc. seeks a regulatory professional to lead and review promotional labeling materials for prescription drugs and medical devices.

The role provides strategic guidance on promotional messaging and ensures compliance with FDA requirements throughout pre-launch and launch activities. You will collaborate with Commercial, Medical, Legal, and Regulatory teams to support launch readiness and promotional strategy while maintaining rigorous standards for regulatory

Qualifications

• 6+ years of experience in pharmaceutical advertising and promotion compliance.
• Experience leading or supporting pharmaceutical product launches, including pre-launch planning and commercialization.
• Experience supporting rare disease products.
• Strong understanding of U.S. regulatory requirements and FDA labeling.

Responsibilities

• Directs or assists staff in reviewing promotional labeling materials and communications for prescription drug and medical device products.
• Reviews and approves promotional materials and provides strategic regulatory guidance on promotional messaging.
• Supports launch planning and cross-functional discussions for pipeline and commercialization activities.
• Monitors regulatory changes and updates departmental processes accordingly.
• Acts as liaison with OPDP and supports regulatory discussions related to promotional strategy.

Skills

Regulatory compliance

Promotional materials review

Cross-functional collaboration

FDA advertising & promotion

Launch experience

Education

Bachelor's Degree

Advanced scientific/clinical degree preferred

Tools

MS Office

Veeva PromoMats

CREDO

Job description

Otsuka America Pharmaceutical, Inc. seeks a regulatory professional to lead and review promotional labeling materials for prescription drugs and medical devices.

The role provides strategic guidance on promotional messaging and ensures compliance with FDA requirements throughout pre-launch and launch activities. You will collaborate with Commercial, Medical, Legal, and Regulatory teams to support launch readiness and promotional strategy while maintaining rigorous standards for regulatory