Associate Director, Regulatory Affairs AdPromo

Essential Duties and Responsibilities

• Leads regulatory strategy and review for one or more therapeutic areas
• Leads regulatory risk assessment discussions for promotional initiatives and advises cross functional stakeholders on compliant approaches
• Direct regulatory review of US / Canadian commercial product and disease state materials/communications directed to HCP, consumer, payor, and investor audiences across various media
• Provides regulatory oversight to ensure promotional materials meet applicable regulatory and company requirements
• Ensures timely review of materials to meet internal timelines, requirements, and compliance with approved product labels
• Leads cross functional regulatory discussions and drives to resolution issues that impact promotional activities
• Provides insights and guidance to multiple functional areas on the development of product messages, assets, programs, tactics, etc.
• Prepares promotional material binders for submission to OPDP in a timely manner, collaborates with HQ submissions team, and ensures materials are archived per company policy
• Reviews concepts, materials, and communications used in scientific exchanges; represents Regulatory Affairs on the Medical Review Committee (MRC)
• Maintains up-to-date knowledge of laws, regulations, and policies enforced by FDA as they relate to advertising/promotion of pharmaceuticals products
• Handles additional duties and special projects, as assigned by the Director of RA Ad/Promo
• Continually assesses ad/promo-related processes to enhance efficiency and compliance
• Monitors competitor advertising to keep abreast of market promotional and advertising strategies
• Monitors OPDP enforcement actions and assesses potential learnings / impact
• Provides strategic regulatory leadership on advertising and promotional initiatives across assigned brands or therapeutic areas
• Serves as the primary regulatory partner to brand teams, advising on promotional strategy, messaging development, and risk mitigation
• Leads complex regulatory discussions and provides authoritative interpretation of FDA advertising and promotion guidance
• Advises senior commercial and medical leadership on regulatory risk associated with promotional initiatives
• May act as the regulatory lead for launch planning and campaign initiatives
• Provides mentorship and guidance to junior regulatory reviewers and cross functional partners on promotional compliance expectations
• Leads or contributes to the development of internal advertising and promotion policies, standards, and training
• Serves as an escalation point for complex promotional review issues

Education and Experience

• Bachelor’s degree required and preferred in a science discipline; advanced degree preferred
• 10+ years of relevant pharmaceutical industry experience, including 6+ years of direct advertising and promotion review experience
• Experience preparing and submitting regulatory documentation to FDA
• Experience preferred in rare diseases

Knowledge and Skills

• Thorough understanding of applicable laws, regulations (mainly 21 CFR 202), and FDA guidance documents related to ad/promo and scientific exchange
• Demonstrated ability to influence cross functional stakeholders and senior leadership
• Strong regulatory risk assessment and decision making capabilities
• Ability to balance regulatory compliance with business strategy
• Ability to interpret compliance letters to industry and to explain their relevance to RRD’s portfolio to various stakeholders
• Familiarity with Canada’s Pharmaceutical Advertising Advisory Board (PAAB) Code a plus
• Demonstrated ability to conduct independent review of materials and tactics
• Demonstrated record of functional representation on committees, strong interpersonal and communication skills
• Solid understanding of the structure and function of product labeling
• Strong organizational skills and attention to detail
• Proficiency reviewing and annotating in Veeva PromoMats (or comparable system) and experience with MS Office
• Familiarity with eCTD requirements and e-submission formats/processes of promotional materials
• Demonstrated ability to manage multiple competing priorities