Senior Director, Regulatory Advertising & Promotion Location: Remote, US (East and Central Time Zones) Industry: Biotechnology / Rare Disease A global biopharmaceutical organization is seeking an experienced Regulatory Advertising & Promotion leader to oversee its Ad/Promo function and provide strategic regulatory leadership across promotional, medical, and corporate communications. This highly visible role will lead an established team while partnering closely with Commercial, Medical, Legal, Regulatory, and senior leadership. Key Responsibilities Lead and provide strategic direction to the Regulatory Ad/Promo team. Own and evolve the global material review process across promotional and non-promotional communications. Provide strategic, risk-based regulatory guidance on promotional activities and product communications. Oversee regulatory review and approval of US promotional, corporate, and medical materials. Lead interactions with FDA OPDP/APLB, including proactive engagement and regulatory inquiries. Serve as regulatory lead on review committees and escalation discussions. Partner cross-functionally to balance business objectives with regulatory requirements. Develop and enhance SOPs, work instructions, and review processes. Qualifications 15+ years of pharmaceutical/biopharmaceutical industry experience, including 5+ years in Regulatory Advertising & Promotion. Deep knowledge of FDA promotional regulations, guidance, and evidentiary standards supporting product claims. Significant promotional and medical review experience. Experience interacting directly with FDA OPDP/APLB. Proven people leadership and cross-functional stakeholder management. Strong judgment and ability to navigate regulatory gray areas through thoughtful risk assessment and mitigation. BS in a scientific discipline required; advanced scientific degree or JD preferred. Rare Disease, Hematology, and/or Oncology experience is a plus. Experience with AI and digital tools is advantageous. Ideal Profile Seeking a collaborative, solutions-oriented Ad/Promo leader who combines deep regulatory expertise with strong business judgment. The ideal candidate can lead autonomously, influence senior stakeholders, develop an experienced team, and provide practical regulatory solutions rather than simply identifying risk.