Director, Promotional Regulatory Affairs (Immunology)
Core
Set US promotional regulatory strategy and guardrails to enable compliant brand execution and accelerate responsible growth for immunology medicines.
Role type
Director, Promotional Regulatory Affairs (Immunology)
Builds
Compliant promotional materials, claims, and labeling strategies for healthcare professionals, consumers, and payers across print, broadcast, digital, and omnichannel.
Domain
US Pharmaceutical/Biotech, Immunology, FDA Regulatory
Required skills
FDA promotional regulations (OPDP/APLB), drug development and labeling processes, risk assessment, cross-functional partnership, training design, process improvement, people leadership
Preferred skills
Advanced degree in life sciences/pharmacy/law, 10+ years US PRA experience, direct OPDP/APLB interaction, MLR process leadership, digital review systems (AZAP), 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 business leadership on asset prioritization; provide global input on US promotion impact; serve as primary liaison with FDA OPDP/APLB; develop and deliver regulatory training; enhance review processes and guidelines; monitor regulatory trends; mentor staff; represent company as SME.
Seniority
Director, hands-on leadership with team management