Regulatory Manager

🕒 Agosto 18

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $106.000 - $151.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 11%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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Precision For Medicine

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

💰 $75.000.000 Private Equity Round em 2015-12

Healthcare • Consulting • Logistics

A Precision For Medicine é uma organização líder especializada em apoiar o desenvolvimento e a comercialização de terapias inovadoras, particularmente em oncologia, doenças raras e condições autoimunes. Com uma gama abrangente de serviços, incluindo gestão de ensaios clínicos, serviços de laboratório e coleta de biospecimens, eles integram capacidades avançadas de biomarcadores e soluções de manufatura para simplificar os complexos processos de desenvolvimento clínico. Sua missão é acelerar a pesquisa e trazer soluções médicas que mudem a vida dos pacientes, superando as ineficiências tradicionais geralmente encontradas no cenário de desenvolvimento farmacêutico.

Descrição

• Provide regulatory guidance throughout the clinical development life cycle • Compile, coordinate, and review applications to Regulatory Authorities, including CTA/INDs, annual reports, amendments, scientific advice or regulatory authority meetings, orphan designations, pediatric planning, and marketing applications • Develop and/or review submission documents for Regulatory Authorities and Ethics Committees to ensure regulatory compliance • Represent Global Regulatory Affairs at project team and business development meetings with external and internal customers • Work within project teams and lead regional or global projects when necessary • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets • Maintain project plans, trackers, and regulatory intelligence tools; keep Regulatory Leadership updated • Assist in developing Regulatory Affairs Specialists and other operational staff • Provide input into regulatory strategy and timelines for new study opportunities • Help establish company standards for high-quality submitted information • Participate in corporate quality initiatives across Clinical Solutions business units • Maintain current knowledge of laws, regulations, and guidelines governing drug development and approval • Provide ICH GCP guidance, advice, and training to internal and external clients

🎯 Requisitos

• Bachelor's degree or equivalent experience, ideally in a scientific or healthcare discipline • Computer literacy, including MS Office/Office 365 • Fluent in English • 5+ years of relevant regulatory affairs experience • Informed knowledge of all aspects of the drug development process, including regulatory milestones • Specialized knowledge of regulatory activities for at least one major region, including the EU or US • Experience with submissions to Regulatory Authorities, including INDs/CTAs, amendments, Scientific Advice Procedures, and post-approval submissions • Ability to understand clinical and pre-clinical study results and interpret them for regulatory positions and strategy • Knowledge of clinical trial methodology, protocols, and indications being studied • Knowledge and expertise in regulations and guidance supporting pharmaceutical development • Availability for domestic and international travel, including overnight stays • Strong interpersonal skills and ability to contribute to a team environment • Professionalism, punctuality, ability to deliver on commitments, and service orientation • Ability to manage multiple varied tasks in a fast-moving environment and maintain good records • Ability to work and plan independently and in a team environment • Ability to motivate project team members to meet timelines and goals • Flexible attitude toward work assignments and learning • Ability to resolve project-related problems and prioritize workload with limited management support • Focus on continuous improvement and process efficiency • Ability to collect consistently high-quality data • Effective verbal and written communication • Proficiency in formal presentations to colleagues, investigative staff, and clients

🏖️ Benefícios

• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation