Vaxcyte

Vaxcyte focuses on developing vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide.

101-250 employees
Founded 2013
$500M post ipo equity
Biotechnology
Public Company

Open Positions2

Remote - USFull-TimeVaccine DevelopmentPosted
  • Develop and execute globally viable clinical regulatory strategies.
  • Develop, author and review regulatory CMC documentation for submission including application documents, correspondence and responses to queries.
  • Provide regulatory guidance for L2, L3 and L4 cross functional development teams.
  • Ensure adherence to current regulatory requirements and alignment with appropriate regulatory guidance (including ICH) and industry best practices.
  • Serve as a primary point of contact with regulatory authorities, i.e., FDA, EMA, MHRA, PMDA, Health Canada, etc., as appropriate.
  • Contribute to the development of product label claims and justifications for clinical outcomes.
  • Lead interactions and negotiations w/global regulatory authorities for reconciliation of specific clinical and pre-clinical issues to expedite regulatory application submissions and approvals.
  • Support regulatory requirements for safety/pharmacovigilance notifications to regulatory authorities.
  • Provide guidance on contemporary regulatory intelligence, statutory legislation and changes in regulatory authority requirements and expectations.
  • Manage cross-functional teams to demonstrate and ensure regulatory compliance.
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About Vaxcyte

Vaxcyte is a clinical-stage vaccine innovation company focused on developing next-generation vaccines to prevent and treat infectious diseases. They are currently advancing vaccines for invasive pneumococcal disease, Group A Strep, periodontal disease, and Shigella. Vaxcyte leverages its XpressCFTM platform, a cell-free protein synthesis platform, to design and produce vaccines in ways that are believed to be superior to conventional technologies. As a biotech company, Vaxcyte is impacting the global health landscape by developing superior vaccines and offering them to the world. They are currently in the process of creating cutting edge vaccines to help combat deadly infectious diseases. Their work environment is guided by core values such as Rethinking Convention, Aiming High, Leading with Heart, and Modeling Excellence. Vaxcyte’s cell-free protein synthesis platform enables the design and production of protein carriers and antigens, the critical building blocks of vaccines, in ways that the Company believes conventional vaccine technologies currently cannot. Vaxcyte has a current tech stack of SPF, Microsoft Exchange Online, Office 365 Mail, Cloudflare Hosting, Microsoft Azure DNS, Cloudflare DNS, WP Engine, Smartsheet, Box, and Dropbox Business, which aids them in their pursuit of creating the most complex biologics. The company's team currently consists of 101-250 employees. They are a public company that has secured funding through post-IPO equity offerings, totaling $3.847 billion in funding rounds. Vaxcyte's stock is publicly traded on the NASDAQ under the symbol PCVX. This role is eligible for relocation assistance.

Tech Stack

mxwidgets