Regulatory Advertising & Launch Strategist (Remote)

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

Benefits offered by this job

Medical/dental/vision

401(k) match

Paid holidays & leave

Education assistance

Job summary

Otsuka America Pharmaceutical Inc. is seeking an experienced regulatory affairs professional to lead and review promotional labeling and communications for prescription drug and medical device products.

You will ensure compliance with FDA advertising and promotion requirements and act as a strategic partner across Commercial, Medical, Legal, and Regulatory teams. The role supports pre-launch and launch activities, with a focus on rare disease programs, training, and cross-functional

Qualifications

• 6+ years of experience in pharmaceutical advertising and promotion compliance within biotech/pharma
• Experience launching or supporting pharmaceutical products (pre-launch, launch readiness)
• Experience supporting rare disease products
• Regulatory guidance provided in cross-functional commercial environments
• Balance regulatory risk with business objectives in fast-paced launches
• Strong understanding of U.S. regulatory requirements and FDA advertising rules
• Educational background in science with advanced degree preferred

Responsibilities

• Review and approve promotional materials to ensure compliance with laws and company requirements
• Provide strategic regulatory guidance during pre-launch and launch activities
• Collaborate across Commercial, Medical, Legal and Regulatory teams for launch activities
• Ensure alignment of promotional materials with approved labeling and regulatory standards
• Train internal staff and affiliates on promotional compliance regulations
• Act as liaison with OPDP and support regulatory discussions as needed
• Manage submission of materials to OPDP using FDA Form 2253

Skills

Regulatory compliance

Launch planning

Cross-functional collaboration

FDA regulations

Promotional messaging

Education

Bachelor’s Degree

Advanced degree preferred (PharmD/PhD/MS)

Tools

MS Office

Veeva PromoMats

CREDO

Outlook

Teams

Adobe Acrobat

Job description

Otsuka America Pharmaceutical Inc. is seeking an experienced regulatory affairs professional to lead and review promotional labeling and communications for prescription drug and medical device products.

You will ensure compliance with FDA advertising and promotion requirements and act as a strategic partner across Commercial, Medical, Legal, and Regulatory teams. The role supports pre-launch and launch activities, with a focus on rare disease programs, training, and cross-functional