Regulatory Strategy Director

🕒 Maio 29

🏄 California, Massachusetts – Remoto

🏄 California – Remote 🍂 Massachusetts – Remote

💵 $150.000 / ano

⏰ Tempo Integral

🔴 Especialista

🚔 Conformidade

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Premier Research

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🧬 Biotecnologia

⚕️ Seguro de Saúde

💊 Farmacêutico

💰 Venture Round em 2016-10

Biotechnology • Healthcare Insurance • Pharmaceuticals

A Premier Research é uma organização líder em pesquisa clínica focada em apoiar empresas de biotecnologia inovadoras na transformação de ideias que mudam vidas e ciência revolucionária em novos tratamentos médicos. Com capacidades extensivas em pesquisa clínica e desenvolvimento de produtos, a Premier Research oferece um conjunto abrangente de serviços, incluindo consultoria regulatória, estudos do mundo real e de fases tardias, e expertise em diversas áreas terapêuticas, como doenças raras, terapia celular e genética, oncologia, dermatologia e pediatria.

Descrição

• Develop and execute regulatory program strategies and contingencies for assigned projects • Lead both US and ex-US regulatory teams on assigned projects • Develop and implement creative approaches to ensure regulatory success • Provide efficient and effective regulatory representation with clients as well as across the organization and act as a key player in interactions with the Food and Drug Administration (FDA) and other regulatory agencies • Serve as the primary point of contact and interface for FDA/EMA/national agencies on assigned projects • Lead the preparation of submissions, which may include INDs, briefing documents, orphan drug applications, breakthrough designations, and NDAs/BLAs/MAAs and others

🎯 Requisitos

• Bachelor’s degree, or international equivalent from an accredited institution, in science or health related field; Master’s Degree or PhD preferred • 12+ years of experience in the CRO, pharmaceutical, biotechnology or device/diagnostics industry; an advanced degree will be considered in lieu of a portion of industry experience • 8-9 years progressive regulatory affairs experience (US and/or ex-US) for a CRO/biotech/pharma of which 4+ years has been as a consultant • Demonstrated experience interacting with the Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory agencies • Demonstrated leadership experience in the opening of INDs and submission and approvals of NDAs/ BLAs/MAAs • Expert in the drug development process with experience in multiple phases (early and late stage, post-approval) in various therapeutic areas and product types (drugs, biologics, drug-drug combinations, drug-device combination products)

🏖️ Benefícios

• health insurance • retirement plans • paid time off