Sr. Regulatory Ad Promo Manager
Core
Leads regulatory review of medical education and commercial advertising/promotional materials for biopharmaceutical products to ensure FDA compliance.
Role type
Senior Regulatory Ad Promo Manager
Builds
Compliant promotional strategies and FDA submissions for neurological, psychiatric, endocrine, and immunological treatments
Domain
Biopharmaceuticals / Regulatory Affairs
Required skills
FDA advertising and promotional regulations expertise, PRC process management, risk assessment, cross-functional leadership, SOP maintenance, mentoring, project management, electronic document management systems proficiency
Preferred skills
None stated
Technologies
Veeva Vault, Microsoft Office, Adobe Professional
Responsibilities
Lead the Promotional Review Committee (PRC) process, represent Regulatory Affairs on the Medical Review Committee, independently review advertising materials, submit FDA Form 2253, evaluate FDA guidance and enforcement trends, foster cross-functional partnerships, ensure claims comply with approved labeling, improve review processes, mentor junior team members
Seniority
Senior, hands-on IC with leadership responsibilities