Senior Regulatory Consultant – Advertising & Promotion (Strategic Lead)

The partnership continues to grow! As a result, we are seeking an additional highly strategic and experienced Senior Regulatory Consultant – Advertising & Promotion to serve as a trusted advisor across cross-functional teams on this dedicated client partnership. This individual will bring deep expertise in FDA advertising and promotion regulations, providing guidance that shapes compliant, effective, and innovative healthcare communications. This role extends beyond execution, requiring a proactive leader who can independently review materials, interpret evolving FDA guidance, and pivot regulatory strategy to support business objectives while mitigating risk.

Key Responsibilities

• Serve as a strategic regulatory partner to cross-functional stakeholders including Medical Affairs, Legal, Commercial, Marketing, and Clinical teams
• Act as a trusted subject matter expert (SME) in FDA Advertising & Promotion regulations, providing high-level guidance on complex regulatory scenarios
• Independently review and approve promotional and non-promotional materials, ensuring compliance with applicable FDA regulations, guidance, and industry standards (e.g., OPDP requirements)
• Proactively interpret and apply FDA guidance, identifying risks and opportunities to inform sound regulatory strategy
• Demonstrate the ability to pivot regulatory strategy based on evolving FDA expectations, enforcement trends, and business needs
• Provide strategic input early in the development lifecycle, influencing messaging, claims, and communication strategy
• Partner with Legal and Medical Affairs to ensure balanced, compliant, and scientifically accurate communications
• Lead discussions on risk assessment and mitigation strategies, offering solutions-oriented recommendations
• Support and, where needed, lead regulatory review committees (e.g., PRC/MLR), driving efficient and compliant review processes
• Stay current with regulatory trends, FDA warning letters, and industry best practices, proactively sharing insights with internal stakeholders
• Mentor junior team members and contribute to building organizational regulatory capability

Qualifications

• 7+ years of experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry, with a strong emphasis on Advertising & Promotion
• Deep and demonstrated knowledge of FDA regulations, guidance documents, and enforcement trends related to promotional activities
• Proven ability to act as a strategic advisor and trusted partner to senior stakeholders
• Extensive experience collaborating with Medical Affairs, Legal, and Commercial teams
• Demonstrated ability to independently review promotional materials and make sound regulatory decisions
• Strong experience in interpreting and applying FDA guidance to real-world scenarios, including the ability to adapt strategies accordingly
• Excellent communication, influence, and stakeholder management skills
• Strong critical thinking and problem-solving abilities, with a proactive and solutions-oriented mindset

Preferred Qualifications

• Experience supporting product launches or high-visibility brands
• Familiarity with global regulatory considerations (nice to have)
• Prior experience leading or facilitating MLR/PRC committees

What Sets This Role Apart

• Opportunity to operate as a strategic, enterprise-level regulatory leader
• High visibility across commercial and medical leadership teams
• Ability to directly influence brand strategy while ensuring compliance and patient safety

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