Senior Manager, Regulatory Strategy

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🕒 Abril 8

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $160.000 - $180.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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Praxis

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2002

🧬 Biotecnologia

⚕️ Seguro de Saúde

🔬 Ciência

Biotechnology • Healthcare Insurance • Science

A Praxis é uma empresa dedicada a conectar pacientes com oportunidades significativas de ensaios clínicos. Com foco na criação de programas de recrutamento personalizados, a Praxis utiliza uma variedade de ferramentas especializadas e vasta experiência em diversas áreas terapêuticas para garantir que alcancem os pacientes certos em todo o mundo. Estabelecida em 2002, a empresa enfatiza a importância do engajamento do paciente e utiliza insights sofisticados de dados para aprimorar a jornada do paciente na pesquisa clínica.

Descrição

• Support the development and execution of global regulatory strategies for ongoing clinical-stage programs, with a strong focus on lifecycle management. • Lead regulatory activities for clinical development programs, including new IND submissions, protocol amendments, annual reports, safety updates, and global CTA maintenance. • Partner with Clinical Development, Nonclinical, CMC, and Translational teams to align regulatory strategy with evolving development objectives and timelines. • Prepare and manage regulatory submissions (e.g., IND amendments, new INDs, CTAs, briefing packages) in collaboration with internal stakeholders and external vendors. • Contribute to preparation for and participation in health authority interactions (e.g., FDA, EMA, MHRA), including meeting strategy, briefing document preparation, and response coordination. • Provide regulatory guidance to cross-functional teams on clinical trial design, patient selection, and regulatory requirements to support lifecycle activities. • Support planning for future marketing applications by ensuring development programs are conducted in alignment with global registration requirements. • Monitor and interpret evolving regulatory guidance and communicate potential impact on ongoing programs. • Contribute to regulatory intelligence efforts and continuous improvement of regulatory processes.

🎯 Requisitos

• Advanced degree (PharmD, MS, or equivalent) in a life science or regulatory-related field preferred; six to ten years of experience in Regulatory Strategy within biotech/pharma. • Demonstrated experience managing IND lifecycle activities, including protocol amendments, new INDs, and global CTA maintenance. • Experience supporting health authority interactions and preparing regulatory briefing packages. • Experience in rare disease and/or neurological indications strongly preferred. • Understanding of accelerated regulatory pathways (e.g., orphan designation, breakthrough therapy) and their application to lifecycle strategy. • Strong project management skills and ability to manage multiple concurrent regulatory activities. • Excellent communication and collaboration skills.

🏖️ Benefícios

• 99% of the premium paid for medical, dental and vision plans. • Company-paid life insurance, AD&D, disability benefits, and voluntary plans. • Dollar-for-dollar match up to 6% on eligible 401(k) contributions. • Long-term stock incentives and ESPP. • Discretionary quarterly bonus. • Extremely flexible wellness benefit. • Generous PTO, paid holidays, and company-wide shutdowns.