Associate Director / Director, Regulatory Advertising and Promotion
About the role
What You'll Do
The Associate Director/Director, Regulatory Advertising & Promotion is responsible for providing strategic regulatory leadership for promotional materials and external communications across assigned programs or brands. This role ensures that all promotional activities are compliant with FDA regulations, industry guidance, and company policy, while enabling the business to communicate effectively and competitively.
In addition to timely review of materials, the Associate Director/Director is expected to help shape messaging strategy early, anticipate regulatory risk and opportunities, and influence cross-functional partners to drive compliant, compelling communications that enable the business to deliver content and messaging effectively to its stakeholders.
Responsibilities
Strategic Regulatory Leadership
- Serve as the Ad Promo regulatory lead for assigned products (commercial and/or pipeline).
- Provide proactive guidance on promotional strategy, claims development, and risk positioning.
- Partner with Commercial, Medical, Legal, and Clinical teams to align messaging with labeling and data.
- Interpret and apply FDA regulations, OPDP guidance, enforcement trends, and industry standards to business initiatives.
- Assess regulatory risk and recommend clear, practical mitigation strategies.
Promotional Review & Governance
- Lead review and approval of promotional materials