Director, US Advertising and Promotional Compliance
Core
Lead therapeutic area regulatory affairs and approve regulatory content for prescription drug promotion, disease awareness, and public affairs communications.
Role type
Director, Regulatory Affairs (Therapeutic Area Lead)
Builds
Approved promotional materials and compliant communication processes for prescription drugs
Domain
Pharmaceutical / Regulatory Compliance
Required skills
US advertising and promotional regulations, FDA/OPDP/APLB liaison, process development, team leadership, risk assessment, global compliance standards
Preferred skills
JD, PharmD, or master's degree
Technologies
None stated
Responsibilities
Review and approve US promotional, non-promotional, and scientific materials; Serve as primary contact for FDA OPDP/APLB communications; Develop SOPs and best practices for ad/promo creation; Provide training on prescription drug promotion requirements; Advise product development teams on promotion issues; Maintain expertise on FDA enforcement actions and communicate new standards; Support key initiatives for promotional review process improvement; Mentor ad/promo colleagues