Remote Director, Promotional Compliance & Launch Strategy

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

Benefits offered by this job

Comprehensive medical, dental, vision,

401(k) match

Paid holidays and paid leave

Job summary

Otsuka America Pharmaceutical Inc. is seeking an experienced regulatory professional to direct or assist staff in reviewing promotional labeling and communications for prescription drug and medical device products.

The role ensures materials meet regulatory requirements and serves as a strategic partner for rare disease launch and commercialization activities. Responsibilities include leading or supporting launches, providing risk-based regulatory guidance in cross-functional teams, and

Qualifications

• Bachelor’s degree required; advanced scientific or clinical degree preferred (PharmD/PhD/MS).
• 6+ years experience in pharmaceutical advertising and promotion compliance.
• Experience supporting product launches, pre-launch planning, and commercialization.
• Strong knowledge of U.S. regulatory requirements for advertising and promotion.

Responsibilities

• Ensures promotional materials comply with laws, regulations, and company requirements.
• Reviews and approves promotional materials and provides strategic guidance on messaging.
• Offers regulatory guidance during pre-launch and launch activities for claims and disease education.
• Partners with Commercial, Medical, Legal, Regulatory teams to support launches.
• Final review and approval of promotional materials, sales training, and corporate communications.
• Supports materials related to complex diseases and FDA reporting requirements.
• Keeps up with changes in U.S. promotional regulations and internal policies.

Skills

Regulatory compliance

Cross-functional collaboration

Strategic guidance

FDA advertising requirements

Launch planning

Communication skills

Education

Bachelor's Degree

Advanced scientific or clinical degree (PharmD, PhD, MS)

Tools

MS Office

Veeva PromoMats

CREDO

Outlook

Teams

Adobe Acrobat

Job description

Otsuka America Pharmaceutical Inc. is seeking an experienced regulatory professional to direct or assist staff in reviewing promotional labeling and communications for prescription drug and medical device products.

The role ensures materials meet regulatory requirements and serves as a strategic partner for rare disease launch and commercialization activities. Responsibilities include leading or supporting launches, providing risk-based regulatory guidance in cross-functional teams, and