Senior Associate, Regulatory Affairs

🕒 Maio 15

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BeOne Medicines

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 2010

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

• Coordinate preparation and execution of US regulatory submissions (INDs, NDAs, BLAs, amendments, supplements) in compliance with FDA regulations and guidance. • Draft regulatory submission documents (e.g., IND components) as required. • Review regulatory documentation to ensure accuracy, consistency, and completeness, and supports the effective execution of regulatory submissions to health authorities. • Serve as the primary execution lead and cross-functional coordinator for assigned U.S. regulatory submissions, ensuring clarity of roles, timelines, and deliverables. • Partner with U.S. Regulatory Strategists to translate regulatory plans into executable submission timelines and deliverable strategies. • Collaborate with Clinical, CMC, Safety, Nonclinical, Medical Writing, Labeling, and to collect and organize FDA submission-ready documents. • Perform Quality control (QC) checks to ensure accuracy, consistency, and compliance with eCTD technical specifications and FDA requirements. • Liaise with Regulatory Publishing to support on-time, first-cycle-quality FDA submissions.

🎯 Requisitos

• BA/BS degree, preferably in a scientific or health-related discipline OR 3+ years of Regulatory Affairs experience, including hands-on support of U.S. IND preparation required. • Experience with CTD/eCTD. • Experience with publishing documents in Adobe Acrobat Professional. • Understanding of FDA structure and working knowledge of FDA and ICH regulatory guidance and regulations is desirable. • Ability to manage multiple US submissions and priorities simultaneously. • Strong organizational and documentation skills. • Ability to work independently and collaboratively under tight FDA-driven timelines.

🏖️ Benefícios

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness • Employee Stock Purchase Plan • Discretionary equity awards