Regulatory Affairs Consultant – Regulatory Generalist

🕒 Outubro 9

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🚔 Conformidade

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Esta empresa já patrocinou vistos H1B no passado.

👻 Score fantasma 16%

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• Aberta há 32 dias.
• As vagas desta empresa costumam ser preenchidas em 21 dias.
• Sem salário divulgado.

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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

• Lead or support authoring, assembly, quality review, and submission management for IND Module 1 content and other U.S. administrative submission components • Maintain tables of contents and submission trackers covering content ownership, status, dependencies, approvals, and publishing readiness • Coordinate regulatory publishing, document management, asset management, and subject matter experts to deliver submission packages • Draft and coordinate FDA forms, cover letters, submission metadata, and administrative documentation • Manage review and approval workflows, resolve content or formatting gaps, and oversee publishing and submission handoffs • Support INDs, NDAs, supplements, amendments, and related health authority correspondence • Author and coordinate health authority meeting requests, briefing documents, meeting packages, and administrative components • Coordinate FDA information request responses, reviews, timelines, and final submissions • Archive health authority correspondence and meeting records with indexing, version control, and traceability • Prepare and coordinate IND and NDA lifecycle submissions, including protocol amendments, investigator updates, CMC amendments, Investigator’s Brochure updates, annual reports, supplements, and post-approval submissions • Author or coordinate regulatory content for PADERs, PBRERs/PSURs, DSURs, Investigator’s Brochures, and periodic or safety-related reports • Conduct regulatory intelligence searches and synthesize findings into decision-oriented presentations • Prepare materials for Global Regulatory Team, governance, and alliance meetings • Coordinate agendas, functional updates, decisions, actions, and program milestone alignment • Represent Regulatory Affairs in Global Regulatory Team, clinical trial, partner, and alliance meetings • Collaborate with Clinical, CMC, Nonclinical, Safety, Quality, Commercial, Regulatory Operations, Publishing, and Asset Management teams • Maintain U.S. regulatory archive logs and file submissions, correspondence, and partner documentation • Upload and manage correspondence and regulatory records from global partners • Maintain indexing, metadata, version control, traceability, and inspection-ready records using RIM, EDMS, and applicable tools • Maintain Form FDA 1572 waiver and clinical documentation trackers, author waiver requests, and support related submissions • Conduct regulatory reviews of study start-up documentation to support IND-level compliance

🎯 Requisitos

• 5+ years of regulatory affairs experience within the pharmaceutical or biotechnology industry • Hands-on experience with IND Module 1 authoring, submission assembly, TOC tracking, and coordination with regulatory publishing or submission operations • Direct experience with IND lifecycle maintenance, including protocol amendments, investigator updates, CMC amendments, and Investigator’s Brochure updates • Experience supporting NDA submissions and lifecycle maintenance, including annual reports and post-approval activities • Experience authoring or coordinating health authority meeting requests, briefing documents, FDA information request responses, and health authority correspondence • Experience contributing to PADERs, DSURs, PSURs/PBRERs, Investigator’s Brochures, or associated regulatory sections • Experience conducting regulatory intelligence research and presenting guidelines or precedents to inform regulatory planning or strategy • Proven ability to prepare Global Regulatory Team, governance, or alliance meeting materials and coordinate cross-functional inputs • Experience working across Clinical, CMC, Nonclinical, Safety, Quality, Regulatory Operations, Publishing, and related functions • Strong regulatory writing, document coordination, and submission management capabilities • Ability to translate guidelines and regulatory precedents into concise, decision-focused presentations • Excellent organization and project management skills across multiple assets, deadlines, contributors, and review cycles • High attention to detail and commitment to submission quality, document control, and inspection readiness • Client-focused, consultative approach with strong interpersonal and cross-cultural communication skills • Ability to work effectively across matrixed, cross-company, and alliance environments • Critical thinking, problem-solving, results orientation, and sound judgment in a fast-moving environment • Excellent written and verbal English communication skills; proficiency in the local language, where applicable • Working knowledge of RIM, EDMS, and electronic submission processes is strongly preferred • Bachelor’s degree in a scientific, technical, or related discipline required • Candidates located in the Eastern or Central time zones of the United States or Canada are preferred

🏖️ Benefícios

• Paid time off • 401(k) match • Life insurance • Health insurance • Additional benefit offerings in accordance with applicable plans • Potential eligibility for additional incentives, bonuses, or other compensation programs • Flexible work environment • Growth opportunities

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