Director/Sr. Director, Regulatory Affairs

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🕒 Outubro 29

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 24%

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vTv Therapeutics

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

💰 $80.000.000 Post-IPO Equity - vTv Therapeutics em 2025-09

Healthcare • Consulting • Logistics

A vTv Therapeutics é uma empresa biofarmacêutica em estágio avançado que desenvolve candidatos a medicamentos orais de moléculas pequenas para o tratamento do diabetes e de outras doenças crônicas. Seu principal programa clínico é o cadisegliatin, um ativador seletivo da glucocinase hepática atualmente em Fase 3, com potencial para ser a primeira terapia oral adjuvante de sua classe à insulina para pessoas com diabetes tipo 1. A vTv concentra-se em melhorar o controle glicêmico e reduzir o risco de hipoglicemia por meio de terapias orais inovadoras, além de manter atividades de relações com investidores e programas de desenvolvimento clínico.

Descrição

• Develop, lead, and execute regulatory strategies through all phases of development from proof of concept through commercialization • Prepare for, lead, and document health authority meetings and liaise with health authorities throughout development • Provide regulatory guidance for internal and external project governance boards • Prepare, coordinate, lead, and author regulatory submissions, including clinical and marketing submissions, annual reports, investigator brochures, amendments, briefing books, responses to health authority information requests, and adverse event reporting • Act as the Regulatory Affairs expert on project teams, providing regulatory strategy and guidance throughout development • Review nonclinical, clinical, and CMC documentation and contribute content related to regulatory oversight and guidance • Collaborate with cross-functional teams and external business partners such as CROs and consultants to refine product development strategy and address regulatory issues • Maintain knowledge of current US and global regulatory requirements and communicate regulatory updates • Participate in external communication reviews with Commercial, Legal, and Medical/Clinical teams • Provide risk assessments of operational deliverables related to health authority guidance and organizational goals • Collaborate with Regulatory Operations to ensure quality and compliant submissions • Facilitate compliance with SOPs and regulatory work practices • Foster collaboration and idea sharing with colleagues • Contribute to Regulatory Affairs budgets, forecasts, and inquiries

🎯 Requisitos

• Bachelor’s degree in a scientific discipline; higher degrees preferred • Minimum of 8+ years of experience in regulatory affairs in pharmaceutical/biotech • Experience with IND activity, global CTAs, DSURs, and Agency briefing documents in US and ex-US • Experience interacting with health authorities and leading teams • Strong working knowledge of FDA and/or ex-US regulations • Ability to develop strategic regulatory plans, facilitate team decisions, effectively negotiate, and execute strategies in a fast-paced clinical-stage biotech environment • Proven success or major involvement in major submissions and/or approvals • Experience with electronic templates, review and submission technologies, and clinical disclosure portals • Detail-oriented, proactive, and capable of balancing strategic leadership with hands-on execution • Exceptional communication skills for engaging regulatory authorities, senior leadership, and internal stakeholders • Skilled at identifying risks, solving complex regulatory challenges, and implementing proactive mitigation strategies • Must be legally eligible for employment in the United States • Must answer whether sponsorship is required now or in the future

🏖️ Benefícios

• Fully remote work arrangement

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