Director, Regulatory Affairs, Promotion and Advertising Review (OPAR)
Core
Lead the review and approval of US promotional materials and serve as the regulatory expert for pharmaceutical advertising to ensure compliance with FDA guidelines and company policies.
Role type
Director, Regulatory Affairs (Promotion & Advertising)
Builds
Compliant promotional strategies and materials for pharmaceutical products
Domain
Pharmaceutical industry, US FDA regulatory compliance
Required skills
FDA Regulations, Pharmaceutical Advertising, Regulatory Strategies, Regulatory Risk, Negotiation, Strategic Thinking, Problem Solving, Policy Implementation, Cross-Functional Teamwork, Detail-Oriented
Preferred skills
Master's/PhD/PharmD in science or healthcare, 10+ years in pharma/biologics regulatory, 5+ years as primary reviewer of advertising
Technologies
None stated
Responsibilities
Manage correspondence with FDA promotional review divisions (OPDP/APLB), propose compliant regulatory strategies for complex promotional concepts, lead development of promotional regulatory strategy including GTPI rationale, provide solutions during labeling and global regulatory meetings, mentor team members and provide training, lead departmental strategic initiatives for regulatory review
Seniority
Director, advanced and independent level