Full Job Description
As a result, we are looking to hire an additional highly strategic and experienced Senior Regulatory Strategist, Advertising & Promotion to join our team. This individual will act as a trusted advisor, collaborating across cross-functional teams within a large, dedicated client partnership-helping to influence regulatory strategy and deliver meaningful impact, all while working remotely.
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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