Director, US Advertising and Promotional Compliance
Core
Therapeutic area lead and Regulatory Affairs representative responsible for reviewing and approving regulatory content for prescription drug promotion, disease awareness, and public affairs communications.
Role type
Director, Regulatory Affairs (Therapeutic Area Lead)
Builds
Promotional materials, disease awareness campaigns, and public affairs communications for prescription drugs.
Domain
Pharmaceutical industry, US advertising and promotional compliance.
Required skills
US advertising and promotional regulations expertise, FDA/OPDP/APLB liaison experience, team leadership, process development, risk assessment, global compliance standards knowledge.
Preferred skills
JD, PharmD, or master's degree.
Technologies
None stated.
Responsibilities
Reviewing US promotional, non-promotional, and scientific material; serving as primary contact for OPDP/APLB communications; developing processes and procedures for material creation and approval; providing training support on prescription drug promotion requirements; advising product development teams on advertising issues; maintaining regulatory expertise and communicating new standards; supporting key initiatives for promotional review process improvement; mentoring colleagues.
Seniority
Director, strategic leadership with hands-on regulatory review.