Senior Director, Head of Regulatory Advertising & Promotion
Location: Fully Remote, US | Candidates must be based in the Eastern or Central time zones
About the Role
We are seeking an experienced Senior Director, Head of Regulatory Advertising & Promotion to lead an established Regulatory Advertising & Promotion function within a growing global biopharmaceutical organization.
This is a highly visible leadership position overseeing a strong team of 6+ regulatory professionals across the US and Canada. While the function has historically focused on North America, its scope is expanding globally through the development and implementation of a new Global Material Review Process.
The Senior Director will serve as a key regulatory partner to Commercial, Medical, Legal, Regulatory, and senior leadership, providing strategic guidance across promotional and non-promotional communications. The successful candidate will bring a pragmatic, risk-based approach to regulatory decision-making and will be comfortable balancing compliance requirements with business objectives.
Key Responsibilities
• Lead, develop, and provide strategic direction to an established Advertising & Promotion team, while empowering experienced team members to operate autonomously.
• Own and continue to evolve the organization’s Global Material Review Process across promotional and non-promotional communications.
• Serve as the senior Regulatory Advertising & Promotion subject matter expert, providing practical, risk-based regulatory guidance to the business.
• Lead regulatory review and approval of US promotional, corporate, and medical communications.
• Lead interactions with FDA OPDP and APLB, including proactive engagement and responses to regulatory inquiries.
• Partner closely with Commercial leadership and cross-functional stakeholders across Medical, Legal, Regulatory, and other functions.
• Lead review committees, escalations, regulatory risk assessments, and mitigation strategies.
• Support the continued development of SOPs, work instructions, governance frameworks, and material review processes.
• Help scale the function as the organization expands its global footprint, integrates acquisitions, and continues to grow.
• Support digital transformation initiatives, including the adoption and advancement of AI-enabled tools, Veeva Vault PromoMats, modular content, and omnichannel capabilities.
• Provide regulatory leadership and strategic guidance in areas where regulations or guidance may not provide a clear-cut answer.
Candidate Profile
The ideal candidate will bring:
• Extensive US Regulatory Advertising & Promotion experience within the pharmaceutical or biopharmaceutical industry.
• Advanced knowledge of FDA promotional regulations, guidance, and enforcement expectations.
• Significant experience with promotional and medical review, including direct exposure to FDA OPDP/APLB matters.
• Proven people leadership experience, ideally leading an established team of senior regulatory professionals.
• A collaborative leadership style with the ability to provide direction without micromanaging.
• Strong executive presence and the ability to effectively partner with Commercial and senior leadership.
• Demonstrated ability to navigate regulatory gray areas, assess risk, articulate rationale, and develop practical solutions rather than automatically defaulting to the most conservative approach.
• An autonomous, hands-on, and entrepreneurial working style, with the ability to succeed in an evolving organization.
• Experience supporting product launches is highly valued.
• Global Advertising & Promotion or global material review experience is a strong differentiator.
• Experience with Veeva Vault PromoMats, modular content, omnichannel strategy, AI, or broader digital transformation initiatives is advantageous.
• Experience supporting organizations through acquisitions, integrations, or periods of significant growth and change is beneficial.
• Therapeutic-area experience is flexible. Experience within Rare Disease, Hematology, and/or Oncology is a plus; however, depth of Advertising & Promotion expertise and leadership experience are the primary considerations.
About the Organization
This opportunity is with a global biopharmaceutical company focused on developing and commercializing innovative therapies for patients with rare and specialty diseases.
The organization has an established international presence across North America, Europe, Asia, the Middle East, and Australia and is continuing to expand its global capabilities and portfolio.
Its therapeutic focus includes areas such as:
• Hematology
• Immunology
• Nephrology
• Rare and specialty diseases
The company combines an established commercial portfolio with an active development pipeline and continues to invest in research, global expansion, acquisitions, and new technologies.
Why This Opportunity
This role offers the opportunity to take ownership of an established and experienced Advertising & Promotion function rather than building one from the ground up. The incoming leader will have significant visibility across the organization and the opportunity to shape the function as its responsibilities expand from a primarily North American model toward a broader global material review strategy.
The position also provides exposure to product launches, organizational growth and integrations, and emerging digital capabilities including AI, modular content, and next-generation promotional review processes.
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