Associate Director, Advertising and Promotional Compliance, US
Core
Regulatory Affairs representative responsible for reviewing and approving regulatory content for prescription drug promotion, disease awareness, and public affairs communications.
Role type
Associate Director, Advertising and Promotional Compliance
Builds
FDA-compliant promotional materials and communications for prescription drugs
Domain
Biopharmaceuticals / Prescription Drug Advertising
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
US advertising and promotional regulations, FDA OPDP/APLB liaison, global compliance standards, new product launch, promotional review software (Veeva Promomats/Medcomms)
Preferred skills
Advanced degree, team leadership, risk assessment, marketing concepts
Technologies
Veeva Promomats, Veeva Medcomms
Responsibilities
Review US promotional and non-promotional/scientific materials; serve as primary contact for FDA OPDP/APLB communications; provide training on regulatory requirements; advise product development teams on advertising issues; communicate labeling changes to stakeholders; develop processes for material approval; maintain expertise on FDA enforcement actions.
Seniority
Senior, hands-on IC with strategic planning