Director, US Regulatory Affairs- Promotional & Advertising

Overview

The Director of USRA Advertising & Promotion will be responsible for providing strategic guidance and leadership relating to promotional activities. The Director will have accountability for review and approval of all promotional and proactive medical materials for assigned marketed products, compounds in development, and disease education. A critical aspect of this role is to enable achievement of business objectives while ensuring compliance with applicable FDA regulations, guidance documents, and company policies. The individual will also serve as the primary liaison for leading interactions with the Office of Prescription Drug Promotion (OPDP) for assigned products. Additionally, the Director will help build the USRA Advertising & Promotion team and capabilities and may be responsible for supervising or mentoring other team members and fostering their development. This position will report to the Senior Director, USRC Advertising & Promotion.

Responsibilities

The Director of USRA Advertising & Promotion will be responsible for providing strategic guidance and leadership relating to promotional activities. The Director will have accountability for review and approval of all promotional and proactive medical materials for assigned marketed products, compounds in development, and disease education. A critical aspect of this role is to enable achievement of business objectives while ensuring compliance with applicable FDA regulations, guidance documents, and company policies. The individual will also serve as the primary liaison for leading interactions with the Office of Prescription Drug Promotion (OPDP) for assigned products. Additionally, the Director will help build the USRA Advertising & Promotion team and capabilities and may be responsible for supervising or mentoring other team members and fostering their development. This position will report to the Senior Director, USRC Advertising & Promotion.

Responsibilities

· Serves as internal subject matter expert on promotional and medical review committees for assigned products to ensure compliance with regulatory requirements while meeting corporate strategic promotional objectives.

· Collaborates with cross-functional teams, including Commercial, Medical, Legal, and other expertise areas for review and approval of promotional materials and materials used in scientific exchange for assigned products.

· Provides guidance and strategic support on proposed claims for products in development and develops Important Safety Information and Brief Summary documents as needed.

· Serves as primary liaison with OPDP for assigned products and manages interactions including responses to regulatory inquiries or actions, preparing high quality submissions for advisory comments, and as needed discussions.

· Educates colleagues on the regulatory environment and provides a risk assessment for proposed communication tactics and strategies.

· Continually develops, revises, and assesses best practices, working instructions, and SOPs for promotional activities to establish standards and consistency across company brands.

· Monitors for OPDP enforcement actions, new or revised legislation, regulations, guidance documents, and industry standards related to prescription drug promotion and communicates to the organization, providing training as needed.

· Works closely with Regulatory Operations in making timely 2253 submissions to OPDP.

· Works closely with Regulatory development colleagues regarding proposed product labeling changes to assess and determine the impact on promotional materials.

· Provides advice regarding clinical trial design elements and labeling needed to support target product profiles and desired commercial claims.

· Helps build the USRA Advertising & Promotion team and capabilities, including support for Veeva PromoMats system updates as needed.

· Other duties as assigned.

 

Minimum Job Requirements

 

Qualifications

· BA/BS degree in science or health related discipline, advanced degree preferred.

· Minimum of 10 years of regulatory affairs experience., including at least 5 years with relevant advertising and promotion review experience.

· Solid understanding of regulatory requirements, particularly in the areas of advertising and promotional activities.

· Depth of knowledge and expertise to navigate the complexities of regulatory affairs for promotional materials.

· Ability to develop and implement regulatory strategies aligned with business goals and market dynamics.

· Experience with cross-functional teams and negotiating, collaborating, and managing risk.

· Effective project management skills to oversee the development, review, and approval of promotional materials, ensuring timely submissions and compliance.

· Ability