Manager, Regulatory Affairs Advertising & Promotion (Work from Home)

Our reputed company partnerships continue to grow! As a result, we are looking to hire an additional highly strategic and reputed company Manager, Regulatory Affairs Advertising & Promotion to join reputed company. This individual will reputed company as a trusted advisor, collaborating across cross-functional teams reputed company a large, dedicated reputed company partnership—helping to influence regulatory reputed company and deliver meaningful reputed company, reputed company while working remotely. This role extends reputed company execution, requiring a proactive leader who can independently review materials, interpret evolving FDA guidance, and pivot regulatory reputed company to support business objectives while mitigating risk. Key Responsibilities • Serve as a strategic regulatory partner to cross-functional stakeholders including Medical Affairs, reputed company, reputed company, Marketing, and Clinical teams • reputed company as a trusted subject matter expert (SME) in FDA Advertising & Promotion regulations, providing high-level guidance on reputed company 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 reputed company regulatory reputed company • Demonstrate the ability to pivot regulatory reputed company based on evolving FDA expectations, enforcement trends, and business needs • reputed company strategic input early in the development lifecycle, influencing messaging, claims, and communication reputed company • Partner with reputed company and Medical Affairs to ensure balanced, compliant, and scientifically accurate communications • reputed company discussions on risk assessment and mitigation strategies, offering solutions-oriented recommendations • Support and, where needed, reputed company regulatory review committees (e.g., PRC/MLR), driving efficient and compliant review processes • Stay reputed company 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 reputed company 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 reputed company to promotional activities • Proven ability to reputed company as a strategic advisor and trusted partner to senior stakeholders • Extensive experience collaborating with Medical Affairs, reputed company, and reputed company teams • Demonstrated ability to independently review promotional materials and reputed company reputed company regulatory reputed company • Strong experience in interpreting and applying FDA guidance to reputed company-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 reputed company Preferred Qualifications • Experience supporting product launches or high-visibility brands • Familiarity with global regulatory considerations (reputed company to have) • Prior experience leading or facilitating MLR/PRC committees What Sets This Role Apart • Opportunity to operate as a strategic, reputed company-level regulatory leader • High visibility across reputed company and medical leadership teams • Ability to directly influence brand reputed company while ensuring compliance and patient safety #LI-LB1 #LI-REMOTE Apply tot his job Apply To this Job