Senior Associate, Regulatory Affairs

🕒 5 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $93.600 - $123.600 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 0%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Por que essa pontuação:

• Aberta há 5 dias.
• As vagas desta empresa costumam ser preenchidas em 41 dias.

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BeOne Medicines

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 2010

🧬 Biotecnologia

🏥 Saúde

💊 Farmacêutico

Biotechnology • Healthcare • Pharmaceuticals

A BeOne Medicines é uma empresa global de oncologia, com sede na Suíça, que descobre e desenvolve tratamentos inovadores mais acessíveis e com maior disponibilidade para pacientes com câncer em todo o mundo. Com um portfólio que abrange hematologia e tumores sólidos, a BeOne está acelerando o desenvolvimento de seu diversificado pipeline de novas terapias por meio de capacidades internas e colaborações. Com uma equipe global em crescimento, formada por mais de 11.000 colaboradores presentes em seis continentes, a empresa está comprometida em melhorar radicalmente o acesso a medicamentos para muito mais pacientes que deles precisam.

Descrição

• Plan, track, and execute U.S. regulatory submissions to the FDA for investigational and commercial products • Coordinate preparation and execution of INDs, NDAs, BLAs, amendments, and supplements • Draft regulatory submission documents, including IND components • Review regulatory documentation for accuracy, consistency, and completeness • Serve as primary execution lead and cross-functional coordinator for assigned U.S. submissions • Translate regulatory plans into executable submission timelines and deliverable strategies with U.S. Regulatory Strategists • Collect and organize FDA submission-ready documents with Clinical, CMC, Safety, Nonclinical, Medical Writing, and Labeling teams • Perform quality-control checks for eCTD technical specifications and FDA requirements • Liaise with Regulatory Publishing to support on-time, first-cycle-quality FDA submissions • Maintain IND, NDA, and BLA archives, version control, document integrity, and inspection readiness • Request FDA application numbers through the CDER NextGen Portal and track FDA correspondence • Use Veeva Vault RIM and submission trackers to monitor milestones, deliverables, and risks • Monitor FDA guidance updates and contribute to continuous improvement of U.S. submission processes • Support regulatory strategies for earliest possible approvals or clearances • Manage preparation, writing, assembly, review, and timely submission of regulatory dossiers in the U.S. and abroad

🎯 Requisitos

• BA/BS degree, preferably in a scientific or health-related discipline, with 2+ years of experience OR 5+ years of Regulatory Affairs experience, including hands-on support of U.S. IND preparation (required) • 3+ years of direct experience preparing and executing FDA submissions (IND, NDA, BLA) and lifecycle management activities • Prior Regulatory Affairs experience; hands-on support of U.S. IND preparation and working knowledge of NDA submissions and related amendments or supplements • Experience with CTD/eCTD • Experience publishing documents in Adobe Acrobat Professional • Working knowledge of FDA and ICH regulatory guidance and regulations is desirable • Familiarity with regulatory systems such as Veeva Vault BRIM and document management tools • Proficiency in Microsoft Office (Word, Excel, PowerPoint) • Ability to manage submission timelines, trackers, and Master Document Lists • Strong organizational and documentation skills • Ability to manage multiple U.S. submissions and priorities simultaneously • Ability to work independently and collaboratively under tight FDA-driven timelines

🏖️ Benefícios

• Annual bonus plan eligibility for non-commercial roles • Discretionary equity awards • Voluntary participation in the Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life insurance • Paid Time Off • Wellness benefits

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