Director, Promotional Regulatory Affairs
Core
Strategic leadership in FDA promotional regulations, providing risk assessments and expert guidance across assigned brands through the MLR approval process.
Role type
Director, Promotional Regulatory Affairs
Builds
Regulatory strategies and compliance frameworks for pharmaceutical brands
Domain
Pharmaceutical/Biotech, US FDA Regulatory Affairs
Required skills
FDA advertising/promotion review, Promotional Regulatory Affairs, Risk assessment, Strategic planning, Regulatory compliance, Stakeholder collaboration, Training delivery, Mentoring
Preferred skills
Advanced degree (PharmD, MS, PhD, JD), Strategic decision influencing, Direct FDA division interaction, Therapeutic area expertise (Oncology, Respiratory, Cardiovascular), Electronic review platforms (VEEVA PromoMats)
Technologies
VEEVA PromoMats
Responsibilities
Review and risk assess promotional materials across segments and media; Develop and implement regulatory strategies; Collaborate on asset prioritization; Advise business leaders on brand strategy; Liaise with OPDP/APLB for FDA reviews; Deliver regulatory training; Mentor staff
Seniority
Director, strategic leadership & mentorship