Director, US Advertising and Promotional Compliance
Core
Lead therapeutic area regulatory affairs and serve as the primary liaison with the FDA for US advertising and promotional compliance of prescription drugs.
Role type
Director, Regulatory Affairs (Therapeutic Area Lead)
Builds
Approved promotional materials, disease awareness communications, and public affairs content for prescription drugs.
Domain
Pharmaceutical industry, US regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
US advertising and promotional regulations expertise, FDA/OPDP/APLB communication and negotiation, team leadership, global compliance standards, risk assessment, process development
Preferred skills
JD, PharmD, or master's degree
Technologies
None stated
Responsibilities
Review and approve regulatory content for product promotion and disease awareness; serve as primary contact for FDA OPDP/APLB communications; develop SOPs and best practices for promotional material review; provide training on prescription drug promotion requirements; advise product development teams on advertising issues; maintain expertise on FDA enforcement actions and communicate new standards; support key initiatives for improving promotional review processes; mentor ad/promo colleagues
Seniority
Director, strategic leadership with hands-on regulatory execution