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, Legal, 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 Legal 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, Legal, 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
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