Director, Regulatory Affairs — Advertising & Promotion

Arcutis Biotherapeutics, Inc.; Northern (KY); Hybrid; USD 200,000 - 220,000; Full time

Job summary

Arcutis Biotherapeutics, Inc. is seeking a Director of Regulatory Affairs Advertising & Promotion to oversee regulatory review of promotional, disease state, and unbranded materials in the US.

The role requires coordinating cross-functionally with Commercial, Legal/Compliance, and Medical teams to ensure compliant solutions. The candidate should have a strong background in promotional regulations, experience with Veeva Vault, and the ability to manage complex negotiations.

Qualifications

• Bachelor’s degree in scientific discipline and 8–10 years of related experience
• Strong understanding of regulatory requirements for promotion of prescription drugs
• Experienced reviewer of promotional material for HCPs and patients
• Knowledgeable about use of social media in prescription drug communications
• Experience with Veeva Vault for materials review
• Ability to work cross-functionally and prioritize in a fast-paced environment

Responsibilities

• Provide regulatory guidance and review for promotional, disease state, and unbranded patient and market access materials
• Review materials in Veeva Vault and actively participate in PRC meetings
• Understand and evaluate perspectives across Commercial, Legal/Compliance, Medical and provide regulatory guidance
• Review and interpret enforcement actions and FDA guidance, updating internal policies as needed
• Develop and implement regulatory ad promo strategy and manage complex negotiations
• Mentor junior members of the Regulatory Affairs Advertising & Promotion Team
• Serve as backup for Executive Director during peak volume and out-of-office times
• Assist in management of 2253 process as backup to the Director of Advertising & Promotion Operations

Skills

Regulatory guidance & review

Veeva Vault experience

Cross-functional collaboration

Verbal & written communication

Education

Bachelor’s degree in scientific discipline

8–10 years related experience

Tools

Veeva Vault PromoMats

Job description

Arcutis Biotherapeutics, Inc. is seeking a Director of Regulatory Affairs Advertising & Promotion to oversee regulatory review of promotional, disease state, and unbranded materials in the US.

The role requires coordinating cross-functionally with Commercial, Legal/Compliance, and Medical teams to ensure compliant solutions. The candidate should have a strong background in promotional regulations, experience with Veeva Vault, and the ability to manage complex negotiations.