Manager, Regulatory Operations

🕒 Outubro 19

🏄 California – Remoto

🏄 California – Remote

💵 $120.000 - $170.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 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 22 dias.
• As vagas desta empresa costumam ser preenchidas em 71 dias.

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Vera Therapeutics, Inc.

SiteLinkedInTodas as Vagas

201 - 500 funcionários

🏥 Saúde

💼 Consultoria

🧬 Biotecnologia

Healthcare • Consulting • Biotechnology

Vera Therapeutics, Inc. é uma empresa de biotecnologia em estágio clínico focada no desenvolvimento de tratamentos para doenças renais imunológicas que melhorem a vida dos pacientes. A empresa está avançando com o Atacicept através do desenvolvimento clínico para nefropatia por IgA (IgAN), conduzindo testes de Fase 2b e Fase 3, e perseguindo programas em nefrite lúpica e outras condições imunológicas. Com sede em Brisbane, CA, a Vera enfatiza o desenvolvimento de medicamentos orientado pela ciência, o engajamento com os pacientes e a sustentabilidade.

Descrição

• Support cross-functional departments with regulatory submission activity • Assist in preparing, publishing, and compiling regulatory submission documents for IND, NDA/BLA, MAA, Swissmedic, CTA, and NDS applications • Analyze and develop processes supporting business needs using the Veeva Vault RIM suite • Format complex Word documents, including tables and graphs, and maintain regulatory style and submission templates • Maintain literature lists and obtain literature copies for regulatory submissions • Format, edit, proof, and create bookmarks and hyperlinks according to guidance and internal processes • Ensure consistency across regulatory submission documents • Support regulatory lifecycle maintenance submissions for IND and BLA applications • Conduct final quality reviews of published documents and submissions before dispatch • Maintain and archive regulatory information, Health Authority correspondence, submission records, and final published files in Veeva Vault RIM • Maintain current knowledge of global regulatory submission requirements, eCTD standards, electronic submission specifications, and Health Authority requirements • Perform other duties as assigned

🎯 Requisitos

• Bachelor’s degree and 5-6 years of experience in Regulatory Operations with specialized skills in electronic submissions • In depth, hands-on experience and expert level skills in Word processing, formatting, and PDF publishing for electronic submissions • Relevant experience with electronic document management and publishing systems, including Veeva Vault RIM, Box, SharePoint, Lorenz DocuBridge, eCTD Validation and viewing tools, and TRS Toolbox • Experience with global regulatory submissions or other experience directly related to Regulatory Operations • Proficiency with MS Word and Adobe is a MUST • Knowledge of Accenture StartingPoint Templates is a plus • Committed to producing high quality and timely deliverables • Ability to work independently and efficiently with Regulatory Affairs • Flexibility, patience, and good verbal, written, and interpersonal communication skills

🏖️ Benefícios

• Annual performance incentive bonus • New hire equity • Ongoing performance-based equity • Medical insurance • Dental insurance • Vision insurance • 401(k) match • Flexible time off • Paid holidays

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