Senior Regulatory Consultant – Advertising & Promotion

🕒 Junho 10

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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Parexel

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1983

⚕️ Seguro de Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 Venture Round em 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel é uma das maiores organizações de pesquisa clínica (CROs) do mundo, oferecendo serviços abrangentes para o processo de desenvolvimento clínico das Fases I a IV. A empresa é especializada em gestão de portfólio, gestão de ensaios clínicos, estratégia regulatória, acesso ao mercado e gestão do ciclo de vida para biofarmacêuticos. A Parexel busca acelerar a chegada de medicamentos que transformam vidas ao mercado, alavancando sua expertise clínica, regulatória e terapêutica. Com uma equipe global de mais de 21. 000 profissionais, a Parexel trabalha para integrar insights de pacientes e desenhos de estudo inovadores a fim de desenvolver tratamentos em áreas terapêuticas como oncologia, neurociência, doenças raras, entre outras. Seu foco está na condução de ensaios clínicos eficientes e centrados no paciente.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development