Senior Regulatory Affairs Consultant - Ad Promo

Senior Regulatory Consultant – Advertising & Promotion (Strategic Lead) We are seeking a highly strategic and experienced Senior Regulatory Consultant – Advertising & Promotion to serve as a trusted advisor across cross-functional teams. 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 #LI-LB1 #LI-REMOTE