Director, Promotional Regulatory Affairs
Core
Strategic leadership in FDA promotional regulations, providing risk assessments and expert guidance on promotional materials for assigned brands.
Role type
Director, Promotional Regulatory Affairs
Builds
Regulatory strategies and compliant promotional assets for pharmaceutical brands
Domain
Pharmaceutical/Biotech, US FDA regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA advertising/promotion review, risk assessment, regulatory strategy development, stakeholder collaboration, departmental guidance creation, FDA liaison management, regulatory training delivery, mentoring
Preferred skills
Advanced degree (PharmD, MS, PhD, JD), strategic decision influencing, direct OPDP/FDA review division interaction, therapeutic area expertise (Oncology, Respiratory/Immunology, Cardiovascular/Renal/Metabolic), electronic review platform familiarity (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; Develop departmental guidance documents; Serve as liaison with OPDP/APLB for FDA reviews and complaints; Assess and deliver regulatory training; Mentor less experienced staff
Seniority
Director, strategic leadership & mentorship