Senior Manager, Regulatory Affairs

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🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $183k - $194k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Vaxcyte

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to prevent and treat serious bacterial infections. The company develops broad-spectrum conjugate and novel protein vaccines—using modern synthetic chemistry and a proprietary cell-free protein synthesis platform licensed from Sutro Biopharma—to create difficult-to-make protein antigens more efficiently. Its lead programs are pneumococcal conjugate vaccine candidates VAX-31 (31-valent) and VAX-24 (24-valent) in Phase 2/3 studies, with earlier-stage candidates targeting Group A Strep and Shigella; Vaxcyte focuses on reducing invasive bacterial disease burden, antibiotic resistance consequences, and related morbidity in vulnerable populations.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

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