Regulatory Advertising Lead for Rare Disease Launch

Otsuka America Pharmaceutical Inc.; Santa Fe (NM); Remote; USD 186,000 - 279,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) match

Paid holidays

Disability insurance

Tuition reimbursement

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. in the United States seeks a Senior Regulatory Affairs Specialist to direct or support approval of promotional labeling for prescription drugs and medical devices, ensuring adherence to FDA advertising and promotion rules.

You will partner with Commercial, Medical, Legal, and Regulatory teams on launch planning, provide risk-based guidance, and review materials for accuracy, audience suitability, and regulatory alignment, supporting rare disease programs.

Qualifications

• Bachelor's degree required; advanced scientific or clinical degree preferred.
• 6+ years in pharmaceutical advertising and promotion compliance.
• Experience leading or supporting pharma product launches, including pre-launch planning and commercialization.
• Strong understanding of U.S. regulatory requirements and FDA advertising rules.
• Excellent written and oral communication skills.

Responsibilities

• Ensure promotional materials comply with laws, regulations, and company requirements.
• Review and approve promotional materials; provide strategic messaging guidance.
• Provide regulatory guidance during pre-launch and launch activities, including claims review.
• Review materials for consistency with labeling and regulatory expectations.
• Collaborate cross-functionally with Commercial, Medical, Legal, and Regulatory teams.
• Approve promotional materials, training materials, and corporate communications.

Skills

Regulatory compliance

Launch experience

Cross-functional collaboration

FDA advertising knowledge

Communication skills

Education

Bachelor's Degree

Advanced scientific degree (PharmD/PhD/MS)

Tools

MS Office (Word/Excel/PowerPoint)

Veeva PromoMats

CREDO

Outlook

Teams

Adobe Acrobat

Job description

Otsuka America Pharmaceutical Inc. in the United States seeks a Senior Regulatory Affairs Specialist to direct or support approval of promotional labeling for prescription drugs and medical devices, ensuring adherence to FDA advertising and promotion rules.

You will partner with Commercial, Medical, Legal, and Regulatory teams on launch planning, provide risk-based guidance, and review materials for accuracy, audience suitability, and regulatory alignment, supporting rare disease programs.