Associate Director, Promotional Regulatory Affairs (BBU)
Core
Lead review and adjudication of promotional materials for pharmaceutical products in the US, ensuring compliance with FDA regulations and applicable laws for business teams.
Role type
Senior individual contributor regulatory affairs specialist (promotional)
Builds
Compliant promotional assets, training programs, and regulatory strategies for AstraZeneca brands
Domain
Pharmaceutical industry, US regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA promotional regulations expertise, drug development process knowledge, risk assessment, regulatory strategy development, training delivery, competitor complaint adjudication
Preferred skills
Experience with VEEVA PromoMats, therapeutic area expertise, cross-functional collaboration, strategic thinking
Technologies
VEEVA PromoMats
Responsibilities
Review and adjudicate promotional materials across all segments and media; manage FDA advisory review requests; develop PRA guidance and job aids; monitor regulatory agency activities and emerging trends; deliver regulatory training; assist in asset prioritization and brand strategy implementation
Seniority
Senior, hands-on IC
