Drive efficient and effective regulatory review and risk assessment for promotional materials across HCP, Consumer, and Managed Markets segments and all media types
Lead innovative regulatory strategy development and implementation
Collaborate with MLR planners, reviewers, and asset owners on asset prioritization and consultation
Provide input to global teams on how proposed documents, labeling, studies, and corporate initiatives may affect US promotion
Serve as primary liaison with OPDP/APLB for assigned brands
Evaluate brand regulatory training needs and develop and deliver training
Follow and enhance established processes and guidelines
Monitor regulatory agency activities, guidance documents, and emerging trends
Shape PRA vision, practices, and operational plans
Act as a role model for performance and ways of working
Represent the company as a subject matter expert

Bachelor’s degree in science
3+ years’ experience in promotional regulatory affairs, FDA (OPDP/APLB), or other equivalent experience in advertising and promotion review
5+ years total experience in pharmaceutical/biotech industry, FDA, or equivalent experience
Strong knowledge of FDA promotional regulations and ability to apply such knowledge in review of diverse promotional materials and audiences
Knowledge of the drug development and labeling processes

Director, Promotional Regulatory Affairs

About this role