Senior Regulatory Affairs Associate – Regulatory Intelligence

🕒 Outubro 22

🌐 Estados Unidos, Canadá – Remoto

🇺🇸 Estados Unidos – Remoto (EUA) 🇨🇦 Canadá – Remoto

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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Parexel

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1983

💼 Consultoria

🏥 Saúde

📦 Logística

💰 Venture Round em 1990-01

Consulting • Healthcare • Logistics

Parexel é uma das maiores organizações de pesquisa clínica (CROs) do mundo, oferecendo serviços abrangentes para o processo de desenvolvimento clínico das Fases I a IV. A empresa é especializada em gestão de portfólio, gestão de ensaios clínicos, estratégia regulatória, acesso ao mercado e gestão do ciclo de vida para biofarmacêuticos. A Parexel busca acelerar a chegada de medicamentos que transformam vidas ao mercado, alavancando sua expertise clínica, regulatória e terapêutica. Com uma equipe global de mais de 21. 000 profissionais, a Parexel trabalha para integrar insights de pacientes e desenhos de estudo inovadores a fim de desenvolver tratamentos em áreas terapêuticas como oncologia, neurociência, doenças raras, entre outras. Seu foco está na condução de ensaios clínicos eficientes e centrados no paciente.

Descrição

• Monitor the regulatory intelligence platform and other information sources to identify and track new and evolving regulations, guidelines, standards, and policies from global regulatory bodies • Review regulatory content for relevance, distribute approved content to key stakeholders for impact assessment and gap analysis, and update stakeholder distribution lists • Collaborate with subject matter experts to assess implications of regulatory changes on products, development pipelines, and business operations • Track implementation of impact assessments and gap analyses with key stakeholders • Analyze and report impact assessment compliance metrics and follow up on risk-mitigation actions • Use the AI-enabled regulatory intelligence platform and dashboards to identify, tag, and summarize GxP-related content and update AI taxonomy terms • Participate in audits and inspections by supplying regulatory intelligence tracking and impact assessment evidence • Maintain familiarity with global standard operating procedures and working procedures in the document management system • Coordinate with Information Technology, Regulatory Technology, and the platform vendor on technical problems, access requests, and distribution issues • Stay current with regulatory intelligence trends and technologies and share learnings to improve compliance activities

🎯 Requisitos

• Minimum of 2 years of work experience in regulatory intelligence • Bachelor's degree in a scientific or technical discipline • Previous experience analyzing and reporting compliance metrics • Solid working knowledge of drug, biologic, and device development processes, and of the laws, regulations, and guidelines from the FDA, EMA, PMDA, and ICH • Ability to plan, direct, organize, and coordinate projects • Excellent interpersonal skills, with strong written and verbal communication • Critical thinking and problem-solving skills • Results-driven, team-oriented collaborative approach • Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) • Experience working in clinical research, healthcare, or a regulated environment • Comfort working with an AI-enabled regulatory intelligence platform, document management systems, and Microsoft Office • Preferred: Minimum of 2 years of regulatory affairs experience • Preferred: Previous interactions with the FDA or other health authorities • Preferred: Previous experience with pharmacovigilance or regulatory work in pharmacovigilance • Preferred: Previous experience developing newsletters

🏖️ Benefícios

• Health, Vision & Dental Insurance • Tuition Reimbursement • Vacation/Holiday/Sick Time • Flexible Spending & Health Savings Accounts • Work/Life Balance • 401(k) with Company match • Pet Insurance • Some roles may also be eligible for additional incentives, bonuses, or other compensation programs

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