Director, US Advertising and Promotional Compliance

Director-level regulatory affairs role overseeing US advertising and promotional compliance for assigned pharmaceutical products. Responsibilities include reviewing promotional materials, liaising with FDA, developing compliance procedures, and providing regulatory guidance to cross-functional teams.

Responsibilities

• Review US promotional, non-promotional, and scientific materials; provide regulatory guidance on FDA compliance standards
• Serve as primary FDA liaison for advertising and promotional regulatory issues on assigned products
• Develop processes, procedures, and best practices for creation, review, and approval of promotional materials
• Provide training on prescription drug promotion requirements for sales and compliance teams
• Advise product development teams on advertising and promotion strategy; mentor ad/promo colleagues

Requirements

• Bachelor's degree minimum; JD, PharmD, or master's degree preferred
• 7+ years pharmaceutical industry experience in regulatory affairs and/or advertising and promotion
• Deep expertise in US advertising and promotional regulations and current regulatory environment
• Direct experience communicating and negotiating with OPDP and/or APLB
• Experience leading teams or managing direct reports
• Strong written, verbal, and interpersonal communication skills
• Demonstrated sound judgment in risk assessment and regulatory knowledge of compliance requirements

Compensation: $193,281-$289,922 base annual salary