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, including risk identification and contingency planning.
Collaborate with MLR planners, reviewers, and asset owners on asset prioritization and consultation; advise business leadership on Brand strategy.
Provide input to global teams on how proposed TPP/TPC/TPL 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 in partnership.
Follow and enhance established processes and guidelines; develop PRA guidance documents and job aids to increase clarity, speed, and quality in review and approval.
Monitor regulatory agency activities, guidance documents, and emerging trends; distill and share implications with PRA and cross-functional partners.
Shape PRA vision, practices, and operational plans; contribute to team objectives and priorities with a focus on measurable outcomes and continuous improvement.
Act as a role model for performance and ways of working; manage, develop, and mentor less experienced staff.
Represent the company as a subject matter expert internally and externally.

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
Advanced degree in life sciences, pharmacy, law, or a related discipline is a plus
10 or more years of experience in US promotional regulatory affairs within biopharma, including direct OPDP/APLB interactions and resolution of advisory or enforcement matters is a plus
Experience leading or co-chairing MLR processes and operating within digital review systems such as AZAP or comparable platforms is a plus
Launch-to-lifecycle leadership across HCP and consumer promotions, managed markets materials, and omnichannel/digital campaigns is a plus
Proven ability to design and deliver effective regulatory training for commercial and medical stakeholders is a plus
Demonstrated influence at senior levels to shape departmental practices and operational plans is a plus
People leadership experience with a track record of coaching and building high-performing teams is a plus.

Director, Promotional Regulatory Affairs

Key skills