Director, Regulatory Affairs – Clinical

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🕒 Abril 22

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $155.000 - $205.000 / ano

⏰ Tempo Integral

🔴 Especialista

🚔 Conformidade

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Loyal

SiteLinkedInTodas as Vagas

51 - 200 funcionários

⚕️ Seguro de Saúde

🤖 Inteligência Artificial

☁️ SaaS

Healthcare Insurance • Artificial Intelligence • SaaS

A Loyal é uma plataforma digital de saúde líder de ponta a ponta, projetada para unificar os pontos de contato de atendimento para pacientes e provedores. Com foco em melhorar a experiência de saúde por meio da tecnologia, a plataforma integra aprendizado de máquina, processamento de linguagem natural e soluções de gestão de dados líderes do setor. A Loyal oferece ferramentas para gerenciamento de dados de provedores e localizações, engajamento digital, otimização de busca de atendimento, autoagendamento de pacientes, IA conversacional, campanhas de CRM, lembretes de consultas e gestão de reputação. Ela ajuda sistemas de saúde a transformarem suas operações, aumentarem o engajamento dos pacientes e melhorarem os resultados de saúde, garantindo acesso contínuo a informações e processos de atendimento.

Descrição

• Authoring and reviewing regulatory submissions, including INAD filings, study reports, clinical trial evaluability meetings, and agency correspondence • Leading preparation for FDA CVM meetings, including  briefing documents, meeting requests, posing questions, and follow-up MOCs • Partnering with clinical teams to provide real-time regulatory guidance on active studies, including SAE submissions, BIMO preparedness, and NCIE reports • Reviewing and preparing study protocols, ICFs, and amendments to ensure the highest quality submissions for pivotal protocol concurrence • Monitoring and interpreting CVM guidance, policy updates, and precedent to inform Loyal's regulatory strategy across our pipeline • Anticipating and resolving regulatory risks across functions (including R&D, CMC, and commercial) throughout the portfolio before they become problems • Managing and mentoring 1–2 direct reports, providing feedback, priorities, and development support • Collaborating cross-functionally with R&D, clinical development, clinical operations, data management, and legal teams on submissions and strategy • Oversee the maintenance and organization of all regulatory records and interactions related to Loyal’s drug programs • Serving as the internal subject matter expert for any question touching FDA CVM clinical requirements — from study design to labeling to adverse event reporting • Reviewing and advising on external facing pre-approval communications and activities to ensure compliance with FDA CVM regulations • Reviewing and providing guidance on labeling materials for submission to ensure compliance with FDA CVM regulations

🎯 Requisitos

• Bachelor’s degree in relevant field (biology, vet med, regulatory affairs or related); relevant experience > specific degree • 10+ years of regulatory affairs experience in animal health with direct experience with owning FDA CVM relationships • Hands on ownership experience with INADs, regulatory submissions, and FDA CVM in-person meetings • Background across multiple drug types ideal (small molecules, biologics, injectables, etc.) • You are data-driven and an analytical thinker; your regulatory experience is grounded in evidence and you communicate with excellence • Strong and experienced writer that takes pride in clarity, accuracy and persuasive story telling about biological pathways or drug mechanisms and clinical impacts • Extensive knowledge of FDA CVM regulatory pathways, policies, and limitations and where there are areas to innovate within those bounds • Excellent judgement where FDA CVM is concerned and comfortable being the single source of strategic conviction using that judgement • Collaborative with cross-functional teams and not afraid to be in the weeds while also being the subject matter expert • Ability to operate as a high level individual contributor while also serving as a mentor to junior team members in order to upskill the department. • Energized by a fast-paced startup environment

🏖️ Benefícios

• Full-coverage health insurance — medical, dental and vision — for you and your dependents • $1,000 home office equipment stipend • $1,200/year learning budget for books, courses, etc. • $250/month wellness budget for gym, cleaners, spa, food, etc. • All 3-day weekends are turned into 4-day weekends 🎉 • Unlimited vacation and paid holidays • Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶 • Competitive salary • Company equity options grant for new hires