Sr. Regulatory Ad Promo Manager
Core
Leading regulatory review of medical education and commercial advertising/promotional materials for biopharmaceutical products to ensure FDA compliance.
Role type
Senior Regulatory Affairs Manager (Advertising & Promotion)
Builds
Compliant promotional strategies and FDA submissions for neurological, psychiatric, endocrine, and immunological treatments.
Domain
Biopharmaceuticals / Regulatory Affairs / Advertising & Promotion
Deliverable
client delivery
Required skills
FDA regulations expertise, Advertising & Promotion process management, Risk assessment, Cross-functional leadership, SOP development, Team mentoring, Project management, Electronic document management systems proficiency, Microsoft Office, Adobe Professional
Preferred skills
None explicitly stated as preferred (all listed under requirements or general competencies)
Technologies
Veeva Vault, Microsoft Office, Adobe Professional
Responsibilities
Lead the Promotional Review Committee (PRC) process, Represent Regulatory Affairs on the Medical Review Committee (MRC), Independently review advertising and promotional materials, Submit FDA Form 2253, Evaluate FDA guidance and enforcement trends, Foster cross-functional partnerships, Ensure communications comply with approved labeling and laws, Navigate complex cross-functional discussions, Assess and improve advertising/promotion processes, Mentor junior team members
Seniority
Senior, hands-on IC with leadership responsibilities
