Director of Regulatory Advertising & Launch Compliance

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

Benefits offered by this job

Comprehensive medical benefits

401(k) match program

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking an experienced Regulatory Compliance professional in the United States to lead or support promotional labeling reviews for prescription drug and medical device products. You will serve as a regulatory partner for rare disease launches and commercialization activities, ensuring materials meet all requirements.

The role demands deep knowledge of U.S. advertising regulations, cross-functional collaboration, and the ability to provide practical,

Qualifications

• 6+ years of experience in pharmaceutical advertising and promotion compliance.
• Experience leading or supporting product launches, including pre-launch and commercialization.
• 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 and product labeling.

Responsibilities

• Ensure promotional materials comply with laws, regulations, and company standards.
• Review and approve promotional materials; provide strategic messaging guidance.
• Support pre-launch and launch activities with regulatory input.
• Coordinate with Commercial, Medical, Legal and Regulatory teams.
• Oversee final review of materials and training content.
• Submit materials to OPDP on FDA Form 2253 and archive per policy.
• Monitor regulatory changes and update departmental processes.

Skills

Regulatory strategy

Cross-functional collaborator

Regulatory risk assessment

Communications excellence

Decision making under launch pressure

Education

Bachelor's Degree

Advanced scientific or clinical degree

Tools

MS Office

Veeva PromoMats

Adobe Acrobat

Job description

Otsuka America Pharmaceutical Inc. is seeking an experienced Regulatory Compliance professional in the United States to lead or support promotional labeling reviews for prescription drug and medical device products. You will serve as a regulatory partner for rare disease launches and commercialization activities, ensuring materials meet all requirements.

The role demands deep knowledge of U.S. advertising regulations, cross-functional collaboration, and the ability to provide practical,