Director Promotional Regulatory Affairs
Core
Set regulatory guardrails for US promotional materials across healthcare professionals, consumers, and payers to ensure compliance and accelerate brand execution.
Role type
Director, Promotional Regulatory Affairs
Builds
Compliant promotional assets, training programs, and regulatory strategies for pharmaceutical brands
Domain
Pharmaceutical/Biotech, US Regulatory Affairs
Required skills
FDA promotional regulations knowledge, drug development and labeling processes, risk assessment, cross-functional partnership, external agency engagement, training development, process excellence, intelligence monitoring, people leadership
Preferred skills
Advanced degree in life sciences/law, 10+ years US PRA experience, direct OPDP/APLB interaction, MLR leadership, digital review systems, launch-to-lifecycle leadership, senior-level influence
Technologies
AZAP, digital review systems
Responsibilities
Drive regulatory review and risk assessment for promotional materials; lead regulatory strategy development and contingency planning; collaborate with MLR planners and asset owners; provide global input on US promotion impact; serve as liaison with FDA OPDP/APLB; develop and deliver regulatory training; enhance review processes and guidelines; monitor regulatory trends; mentor staff; represent company as subject matter expert
Seniority
Director, strategic leadership and team management