Director, Promotional Regulatory Affairs

Role Overview

• 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 that safeguard brands while enabling bold, compliant storytelling
• Collaborate with MLR planners, reviewers, and asset owners on asset prioritization and consultation; advise business leadership on Brand strategy to ensure claims and evidence align with regulatory expectations
• 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; manage requests for FDA advisory review, address enforcement actions, and adjudicate incoming/outgoing competitor product complaints to protect brand integrity
• Evaluate brand regulatory training needs and develop and deliver training in partnership with internal/external Learning teams or the PRA Skill Center
• Follow and enhance established processes and guidelines; develop PRA guidance documents and job aids that 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 to inform proactive planning
• 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 to elevate team capability
• Represent the company as a subject matter expert internally and externally, reinforcing credibility and thought leadership in promotional regulatory affairs

Requirements

• 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

Benefits

• Health insurance
• 401(k) matching
• Flexible work hours
• Paid time off
• Professional development