Senior Regulatory Document Formatting Specialist

March 11

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $122k - $142k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

Apply Now

Receive Emails with Similar Jobs

Vaxcyte

WebsiteLinkedInAll Job Openings

Vaxcyte is a biotechnology company focused on developing innovative vaccines to combat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella. Utilizing advanced chemistry and synthetic techniques, Vaxcyte aims to improve upon existing vaccines with products like their VAX-24 and VAX-31 pneumococcal conjugate vaccines, which target a broad range of bacterial strains. Vaxcyte's approach includes re-engineering the vaccine-making process through the XpressCF™ cell-free protein synthesis platform, aiming to create vaccines that effectively counter bacteria's complex defense mechanisms while maintaining immunogenicity. Their pipeline includes several high-fidelity, broad-spectrum vaccine candidates designed to address significant public health challenges and prevent bacterial infections worldwide.

51 - 200 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. • This role in Regulatory Operations will format and finalize documents for regulatory submissions. • Ideal candidates will have experience formatting complex documents, in-depth understanding of Microsoft Word and Adobe Acrobat Pro, and familiarity with using document templates. • This role will assist with regulatory submission planning, preparation, and QC to ensure high quality, timely submission of regulatory filings to health authorities.

🎯 Requirements

• Minimum 8 years of industry experience and at least 2 years of Regulatory Operations with formatting/word processing documents for regulatory submissions preferred. College degree, AA/AS or BA/BS. Other combinations of education and/or experience may be considered. • Comprehensive knowledge of formatting and document assembly using MS Word including Track Changes and Comments functions and document styles. • Proficient with Adobe Acrobat Pro, PowerPoint, and Excel. • Excellent attention to detail and organizational/time-management skills. • Must work well with others. • Must be accountable, adaptable, and dependable. • Accustomed to fast-paced, highly regulated environment with the ability to work independently. • Familiarity with Veeva RIM is a plus. • Experience using document templates; familiarity with OmniTemplates a plus. • Sound business ethics, including the protection of proprietary and confidential information, is required.

🏖️ Benefits

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