Director, US Advertising and Promotional Compliance
Core
Therapeutic area lead and Regulatory Affairs representative responsible for reviewing and approving regulatory content for product 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, FDA enforcement actions, OPDP/APLB communication, process development, team leadership, risk assessment, global compliance standards.
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 communications with OPDP and/or APLB; developing processes and procedures for advertising and promotional materials; providing training support within the company; advising product development teams on advertising and promotion issues; maintaining regulatory expertise and communicating new standards; participating in key initiatives for promotional review process; supporting and mentoring colleagues.
Seniority
Director, strategic leadership with direct reports.