Senior Manager, Regulatory Affairs

🕒 6 dias atrás

🏄 California – Remoto

🏄 California – Remote

💵 $183.000 - $194.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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Vaxcyte

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2013

🧬 Biotecnologia

💊 Farmacêutico

Biotechnology • Pharmaceuticals

A Vaxcyte é uma empresa inovadora em vacinas em estágio clínico, projetando vacinas de alta fidelidade para prevenir e tratar infecções bacterianas graves. A empresa desenvolve vacinas conjugadas de amplo espectro e novas vacinas de proteína—utilizando química sintética moderna e uma plataforma proprietária de síntese de proteínas sem células licenciada da Sutro Biopharma—para criar antígenos de proteínas difíceis de serem produzidos de forma mais eficiente. Seus programas principais são os candidatos a vacina conjugada pneumocócica VAX-31 (31-valente) e VAX-24 (24-valente) em estudos de Fase 2/3, com candidatos em estágio inicial direcionados ao Grupo A Strep e Shigella; a Vaxcyte foca na redução da carga de doenças bacterianas invasivas, consequências da resistência a antibióticos e morbidade relacionada em populações vulneráveis.

Descrição

• Represent Regulatory Affairs in various internal cross-functional project teams, improvement initiatives and providing regulatory positions on various CMC related topics. • Manage the collection, review, coordination, and preparation of documentation for regulatory CMC submissions, including maintaining comprehensive trackers for documentation requests and timelines. • Manage preparation of responses to queries from regulatory authorities. • Ensure conformance to commitments made with various regulatory agencies. • Collaborate with cross-functional project teams and external business partners to develop regulatory strategies and identify regulatory risks. • Manage coordination, preparation, and timely submission of regulatory documents and filings. • Review and approve change controls related to proposed product/process changes and assess their impact against regulatory requirements. • Cultivate productive working relationships with the Regulatory team and other departments. • Coordinate responses to CMC-related queries from Health Authorities.

🎯 Requisitos

• Bachelor of Science in a scientific discipline (Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices). • 9+ years of experience working in vaccine or biotech industry, or in a related field, or the equivalent combination of education and experience. • Prior experience preparing/authoring CMC DS sections: • BLA highly preferred. • IND highly preferred. • IMPD. • Prior development or manufacturing experience is a plus. • Experience with module 32S and 32P. • Computer software skills (LIMS, SAP, TrackWise, Veeva will be used). • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency. • Applies in-depth understanding of how own discipline integrates within the function and understands contribution to Vaxcyte’s achievement of business objectives.

🏖️ Benefícios

• The compensation package will be competitive and includes comprehensive benefits and an equity component.