About this role

Drive efficient and effective regulatory review and risk assessment for promotional materials across HCP, Consumer, and Managed Markets segments
Lead innovative regulatory strategy development and implementation, including risk identification and contingency planning
Collaborate with MLR planners, reviewers, and asset owners; advise business leadership on Brand strategy
Provide input to global teams on how proposed documents may affect US promotion
Serve as primary liaison with OPDP/APLB for assigned brands; manage requests for FDA advisory review
Evaluate brand regulatory training needs and develop and deliver training
Follow and enhance established processes and guidelines
Monitor regulatory agency activities and distill and share implications
Shape PRA vision and operational plans; contribute to team objectives

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

Key skills