Head of U.S. Regulatory Advertising & Promotion and Strategic Commercialization in United States at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Head of U.S. Regulatory Advertising & Promotion and Strategic Commercialization in United States.

This senior leadership role sits at the intersection of regulatory compliance, commercial strategy, and pharmaceutical innovation, with a focus on shaping and governing advertising and promotional practices across the U.S. market. You will serve as the primary regulatory authority for FDA advertising and promotion compliance, ensuring that all commercial and medical communications meet the highest standards while enabling effective product differentiation. The role is highly strategic, supporting launch readiness, lifecycle management, and cross-functional commercialization efforts across multiple therapeutic areas. You will partner closely with Commercial, Medical Affairs, Legal, and Market Access teams to balance compliance with business impact in a rapidly evolving biotech environment. In addition, you will help modernize regulatory processes through digital transformation and AI-enabled review capabilities. This is a high-visibility leadership position where your decisions directly influence brand strategy and patient access to innovative therapies.

In this role, you will be responsible for leading U.S. regulatory strategy for advertising, promotion, and commercialization activities across the product lifecycle, ensuring compliance while enabling strategic business objectives. You will guide regulatory governance, shape promotional frameworks, and support enterprise-wide launch and growth initiatives. Key responsibilities include:

• Providing expert leadership on FDA advertising and promotion regulations, including OPDP guidance, enforcement trends, and compliance standards
• Overseeing regulatory review and approval of promotional and medical education materials across multiple channels (HCP, consumer, digital, omnichannel, congress, and speaker programs)
• Serving as the primary interface with FDA OPDP, including advisory submissions, correspondence, and regulatory engagement
• Translating regulatory enforcement actions into internal standards and best practices to strengthen compliance frameworks
• Partnering with cross-functional teams to enable compliant messaging, product differentiation, and value communication strategies
• Supporting launch readiness, labeling strategies, claims development, and lifecycle commercialization planning
• Leading the evolution of U.S. advertising and promotion capabilities to support multiple simultaneous product launches
• Driving modernization of MRC/MMRC processes, incorporating automation, AI, and digital content approaches
• Building governance frameworks and ensuring consistent regulatory interpretation across brands and therapeutic areas
• Leading, mentoring, and developing a high-performing U.S. regulatory advertising and promotion team
• Providing training and strategic guidance to internal stakeholders on regulatory requirements and risk-based decision-making
• Contributing to long-term commercialization strategy and enterprise growth across multiple assets

This position requires deep regulatory expertise in FDA advertising and promotion within the pharmaceutical or biotech industry, combined with strong leadership and strategic commercialization experience. The ideal candidate is an innovative, digitally minded leader who can operate effectively in a highly matrixed, fast-paced environment. Key qualifications include:

• 15+ years of regulatory affairs experience, including 5–7+ years focused on advertising and promotion
• Extensive knowledge of FDA advertising and promotion regulations, OPDP guidance, and enforcement landscape
• Proven leadership experience in matrixed organizations supporting complex product launches
• Strong background in pharmaceutical commercialization, lifecycle strategy, and cross-functional collaboration
• Experience guiding regulatory review processes for promotional and medical communications
• Ability to balance compliance requirements with commercial strategy and business objectives
• Strong executive communication and stakeholder management skills
• Demonstrated ability to lead teams, build governance structures, and influence at senior leadership level
• Digital fluency with experience or openness to AI-enabled regulatory processes and modernization initiatives
• Strategic mindset with strong problem-solving and risk-based decision-making capabilities

• Competitive base salary range: $268,000 – $368,500 USD annually
• Eligibility for short-term and long-term incentive programs
• Comprehensive health, dental, and vision insurance
• Retirement savings plans with employer contributions
• Strong focus on professional growth and leadership development
• Exposure to cutting-edge biotech innovation and global commercialization strategies
• Inclusive and equal opportunity workplace culture
• Opportunity to shape enterprise-wide regulatory transformation and digital modernization
• Additional benefits subject to plan terms and eligibility (wellness, financial, and family support programs)