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As a result, we are looking to hire an additional highly strategic and experienced Manager, Regulatory Affairs 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

#LI-LB1

#LI-REMOTE

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