Regulatory Submissions Coordinator, Biological Products

🕒 Junho 17

🌐 México, Argentina – Remoto

🇲🇽 México – Remoto 🇦🇷 Argentina – Remoto

⏰ Tempo Integral

🟡 Pleno

🟠 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

• Support the coordination, preparation, and delivery of regulatory submissions and lifecycle management (LCM) activities • Assist in organizing submission team meetings • Coordinate, request, and track documentation from Subject Matter Experts (SMEs) • Support the preparation and maintenance of the Submission Content Plan (SCP) • Ensure timely dispatch of non-eCTD submission packages • Provide hands-on operational support for labeling activities • Prepare annotated labeling documents for regulatory review • Initiate and coordinate mock-up requests in the Artwork Management System • Track print releases as required • Support change control activities related to local labeling updates • Ensure appropriate archiving of labeling documentation • Support the creation, maintenance, and accuracy of submission and regulatory records in regulatory systems • Upload Module 1 and non-eCTD submission documents to DocNet • Update regulatory systems with Health Authority interactions • Provide regular status updates to the Regional Submission Coordinator (Lead) • Support tracking of submission milestones, deliverables, and dependencies • Collaborate effectively with cross-functional teams • Perform assigned activities in compliance with applicable SOPs, work instructions, and regional regulatory requirements

🎯 Requisitos

• Bachelor's degree in Life Sciences, Pharmacy, or a related discipline • Associate: 1–3 years of experience, Sr Associate +3 years in regulatory affairs, regulatory operations, or a related pharmaceutical/biotechnology role • Experience with Biological Products (Mandatory) • Experience with regulatory submission processes and lifecycle management activities • Experience with Veeva RIM and document management tools • Effective written and verbal communication skills in English and Spanish (mandatory) • Strong organizational skills with attention to detail and quality • Ability to manage multiple tasks and timelines in a matrix environment

🏖️ Benefícios

• Health insurance • 401(k) • Flexible work arrangements • Paid time off • Professional development