Associate Director Regulatory Ad/Promo

Associate Director, Regulatory Affairs Advertising & Promotion

The Associate Director, Regulatory Affairs Advertising & Promotion is responsible for providing regulatory oversight and guidance for commercial communications, promotional materials, and product labeling activities. This individual will serve as a key regulatory partner to cross-functional teams, supporting the review and approval of marketing and promotional materials while ensuring compliance with applicable regulatory requirements and industry standards.

The role will also oversee promotional review processes, support interactions with regulatory authorities regarding advertising and promotion matters, and manage systems and procedures associated with the review, approval, and submission of commercial materials.

Key Responsibilities

• Provide strategic regulatory guidance for advertising, promotion, and product communications in support of commercial objectives while maintaining compliance with applicable regulations and industry standards.
• Serve as a regulatory representative on cross-functional review committees responsible for the evaluation and approval of promotional and medical communications.
• Review, approve, and provide oversight for promotional materials, product communications, advertising campaigns, digital content, sales training materials, and other external-facing communications.
• Support development and implementation of regulatory strategies related to labeling, advertising, and promotion for marketed products.
• Assess promotional claims, messaging, and scientific content to ensure consistency with approved product labeling, appropriate risk communication, and adequate claim substantiation.
• Collaborate with commercial, medical, legal, and compliance stakeholders to evaluate regulatory risks and provide practical, risk-based recommendations.
• Support the development, implementation, and maintenance of product labeling and associated promotional claims documentation.
• Evaluate the impact of labeling updates, regulatory decisions, and evolving guidance on existing and planned promotional materials.
• Monitor regulatory developments, enforcement trends, guidance documents, and industry best practices related to advertising, promotion, and labeling.
• Support interactions with regulatory authorities on advertising and promotion matters, including preparation of submissions, responses, and meeting materials when required.
• Participate in cross-functional discussions regarding labeling strategy and the commercial impact of regulatory decisions.
• Develop written regulatory assessments, recommendations, and position statements related to promotional and labeling activities.
• Provide training and education to internal stakeholders regarding promotional compliance requirements, review processes, and regulatory expectations.
• Foster a culture of compliance while enabling business objectives through effective regulatory partnership.
• Support continuous improvement initiatives related to promotional review processes, governance, systems, and standard operating procedures.
• Perform additional responsibilities as needed to support departmental and organizational objectives.
• Operational Responsibilities
• Manage and support promotional review workflows and associated electronic review and document management systems.
• Coordinate the preparation and submission of promotional materials and related regulatory documentation.
• Maintain processes, procedures, and records supporting advertising and promotion review activities.
• Ensure appropriate documentation, tracking, archiving, and compliance of promotional review activities.

Qualifications

• Bachelor's degree with 8+ years of regulatory affairs experience, Master's degree with 6+ years of experience, or PhD with 5+ years of experience.
• Significant experience supporting advertising and promotion, product labeling, regulatory strategy, or commercial regulatory affairs activities.
• Strong understanding of FDA regulations, industry guidance, and compliance requirements governing promotional communications and product labeling.
• Ability to interpret complex regulations and provide practical, risk-based recommendations.
• Demonstrated experience reviewing promotional materials and advising cross-functional stakeholders.
• Strong analytical skills with the ability to evaluate complex situations and communicate clear recommendations.
• Excellent written, verbal, and interpersonal communication skills.
• Ability to influence and collaborate effectively across cross-functional teams and organizational levels.
• Strong organizational and project management capabilities.
• Ability to thrive in a dynamic, fast-paced environment while managing multiple priorities.