Regulatory Affairs Consultant – Clinical Regulatory Affairs

🕒 Maio 29

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🚔 Conformidade

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Parexel

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1983

⚕️ Seguro de Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 Venture Round em 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

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

• Serve as Regulatory Affairs Lead for 5+ clinical studies within a dedicated client team • Provide strategic regulatory guidance to cross‑functional study teams navigating complex and evolving global requirements • Assess regulatory impact of protocol amendments, informed consent form (ICF) updates, and other study changes • Determine whether updates are substantial or non‑substantial in accordance with applicable regulations • Advise teams on regulatory pathways, processes, and solutions for emerging trial issues • Plan, coordinate, and author health authority meeting requests and scientific advice packages, as required • Lead preparation and coordination of responses to health authority questions and requests for information • Manage regulatory communication strategy for assigned studies • Ensure timely and compliant submission of annual reports and safety updates • Participate in regular study team meetings to track trial progress and proactively surface regulatory considerations • Provide clear and accurate updates to client management on regulatory status, risks, and upcoming milestones • Act as the primary regulatory point of contact for study teams and client stakeholders • Maintain accurate, current regulatory tracking systems in accordance with Parexel and client standards • Ensure all regulatory documentation meets quality expectations and agreed timelines • Support ad hoc study needs and contribute to continuous improvement and departmental initiatives

🎯 Requisitos

• At least 5 years of regulatory affairs experience to include previous clinical regulatory affairs experience • A minimum of a bachelor’s degree in a scientific or technical discipline, advanced degree strongly preferred • Knowledge of FDA Regulations and previous experience with FDA meeting requests and other packages. Experience with other global Health Authorities and applicable regulations are strongly preferred • Project management / leadership experience • Excellent interpersonal and intercultural communication skills, both written and verbal • Client-focused approach to work (Quality) • Results orientation • Teamwork and collaboration skills • Consulting skills • Critical thinking and problem-solving skills • Proficiency in local language and extensive working knowledge of the English language

🏖️ Benefícios

• Work in a dedicated partnership model with strong client trust and visibility • Be part of a global organization known for regulatory leadership and scientific excellence • Collaborate with talented, purpose‑driven colleagues across functions and regions • Make a meaningful contribution to clinical programs that put patients first