Director, Promotional Regulatory Affairs (Respiratory)
Core
Set US promotional regulatory strategy and guardrails to enable compliant brand execution and accelerate responsible growth for respiratory medicines.
Role type
Director, Promotional Regulatory Affairs (Respiratory)
Builds
Compliant promotional materials, training programs, and regulatory guidance for healthcare professionals, consumers, and payers.
Domain
Pharmaceutical/Biotech, Respiratory, US Promotional Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA promotional regulations expertise, risk assessment, cross-functional partnership, global regulatory input, external agency liaison, training development, process improvement, team mentorship, subject matter representation
Preferred skills
Advanced degree in life sciences/pharmacy/law, 10+ years US PRA experience, OPDP/APLB interaction, MLR 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 across HCP, Consumer, and Managed Markets; Lead regulatory strategy development and contingency planning; Collaborate with MLR planners and asset owners on prioritization; Provide global input on US promotion impact; Serve as primary liaison with OPDP/APLB for FDA advisory reviews and enforcement actions; Develop and deliver regulatory training; Enhance review processes and guidelines; Monitor regulatory trends and share implications; Shape departmental vision and operational plans; Manage and mentor staff; Represent the company as a subject matter expert
Seniority
Director, hands-on leadership with team management