Regulatory Affairs Consultant, CMC – Biologics

🕒 Outubro 28

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ 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 Regulatory Affairs leads in developing CMC regulatory strategies and contingency plans for biologic and small molecule drug substances, drug products, and drug-device combination products • Support CMC regulatory strategies for development-phase products from early development through marketing applications and post-approval changes • Determine regulatory, scientific, and technical requirements for CMC and GMP-related submissions and inquiries • Prepare, coordinate, and review CMC and GMP-related documents for submission to regulatory authorities • Represent CMC Regulatory Affairs in project team meetings and provide regulatory guidance to cross-functional teams • Support preparation for health authority CMC meetings, including mock meetings and meeting planning • Support monthly CMC GRT meetings with global cross-functional teams • Interact with manufacturing and quality groups, partner organizations, and other stakeholders on CMC issues • Develop and maintain collaborative relationships with CMC Regulatory Affairs, manufacturing sites, Quality, Technical Operations, affiliates, external partners, contract manufacturers, packagers, and suppliers • Prepare departmental job procedures • Assess and develop innovative ideas to optimize CMC Regulatory Affairs departmental processes, improve efficiencies, and address current and future challenges • Provide CMC regulatory strategy input and expertise for investigational, new, and marketed biologic and small molecule drug products • Support compliance with global regulatory requirements and guidance, with primary responsibility for the US, EU, and Canada

🎯 Requisitos

• Bachelor's degree in Pharmaceutical Sciences or Chemistry, or a Pharm.D. • 4-6 years of CMC experience in the pharmaceutical industry, with a history of successfully preparing regulatory filing documentation • Comprehensive knowledge of the drug development process, pharmaceutical technology, drug manufacturing processes, GMP, and related issues • Knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval, including biologic upstream and downstream processes, analytical methods, and drug-device combination products • Comprehensive knowledge and experience preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for the FDA and equivalent submissions for Europe and Canada • Comprehensive understanding of the global regulatory environment • Demonstrated experience with Microsoft Word, Excel, PowerPoint, and Outlook • Strong analytical, problem-solving, organizational, and negotiation skills • Strengths in proactive strategic thinking, analytical problem solving, and negotiation • Experience working in the pharmaceutical industry within a regulated environment • Strong collaborative, communication, and presentation skills, with the ability to lead meetings and work effectively in a matrixed environment and across cultural lines • Ability to prepare high-quality technical documents and submissions using internal systems • Ability to independently manage and prioritize a multi-project workload • Proficiency with document management and regulatory information systems, Trackwise Digital, and TRS Viewer • Preferred: Master's or Ph.D. degree, preferably in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology • Preferred: Regulatory Affairs Certification (RAC) • Preferred: Experience in CPP application filing through eCATS and 510(j)(3) reporting through nextGen portals

🏖️ 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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