--- title: 'Sr. Manager, Regulatory Affairs at Vaxcyte' canonical: 'https://feeny.ai/job/sr-manager-regulatory-affairs-vaxcyte-san-carlos-california-x9k5b2z49y8s' type: 'job' last_seen: '2026-09-14' --- # Sr. Manager, Regulatory Affairs at Vaxcyte - **Company:** Vaxcyte - **Location:** San Carlos California, United States - **Posted:** 2026-06-16 - **Last confirmed live:** 2026-09-14 - **Apply:** https://boards.greenhouse.io/vaxcyte/jobs/4918369008?gh_jid=4918369008 ## Job description Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values: *RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered. *AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. *LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives. *MODEL EXCELLENCE:  The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making. Summary: A hands-on role providing both strategic and operational activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation and filing of regulatory CMC submissions. Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development. Conducts routine regulatory surveillance and communicates new/changing regulations. Essential Functions: - 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 asses 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 3.2S and 3.2P. - 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. Reports to: Executive Director, Regulatory CMC Location: US - Remote Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Remote Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component. Salary Range: $183,000 - $194,000 (SF Bay Area). Salary ranges for non-California locations may vary. Relocation: This role is not eligible for relocation assistance. ## Equal Opportunity We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. Recruitment Fraud Notice Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at [vaxcyte.com/careers](https://vaxcyte.com/careers/). ## About Vaxcyte ## Company Overview - **One-liner**: Vaxcyte is a clinical-stage biotechnology company re-engineering how vaccines are made to eliminate bacterial infections, using a cell-free protein synthesis platform to develop high-fidelity, broad-spectrum vaccines. - **Entity Type**: Public (Ticker: PCVX) - **Headquarters**: San Carlos, California, United States - **Founded**: 2013 (as SutroVax; rebranded to Vaxcyte in 2020) - **Founders**: Not publicly available (the company emerged from Sutro Biopharma’s spin-out) ## Core Business - **Primary industry**: Biotechnology / Vaccines (Infectious Disease) - **Target customers**: Global healthcare systems, public health organizations, and ultimately patients (B2B/Institutional); the company develops vaccines for both pediatric and adult populations. - **Mission or purpose**: To protect humankind from the consequences of bacterial infections, eliminating diseases like invasive pneumococcal disease, Group A Strep, and Shigella. ## Products & Services - **VAX-31 (31-valent PCV)**: A broad-spectrum pneumococcal conjugate vaccine candidate in Phase 3 for adults and Phase 2 for infants. Designed to cover over 95% of circulating IPD serotypes in U.S. adults 50+ and ~94% in infants. FDA Breakthrough Therapy designation granted. - **VAX-24 (24-valent PCV)**: A pneumococcal conjugate vaccine candidate in Phase 2 for infants, designed to cover more serotypes than any infant PCV on the market today. - **VAX-A1 (Group A Strep)**: A preclinical conjugate vaccine candidate for Group A Strep, a disease with no currently approved vaccine. Phase 1 first-in-human study (adults) underway in Australia. - **VAX-GI (Shigella)**: A novel preclinical vaccine candidate targeting Shigella, a leading cause of diarrheal disease. - **Platform Technology**: A proprietary cell-free protein synthesis platform that enables site-specific, carrier-sparing conjugation to produce precisely targeted vaccines with enhanced immunogenicity. ## Market Standing - **Valuation/Market Cap**: ~$16.7 billion (as of early July 2026) - **Key Metric**: Total funding raised (private) is not applicable; as a public company, key metrics include cash position (~$2.0 billion as of Q1 2026) and R&D investment. The company is pre-revenue. - **Notable Investors/Partners**: Major institutional investors include Baker Bros. Advisors, Fidelity, and funds managed by BlackRock. Key partnership: exclusive license agreement with Sutro Biopharma for its cell-free protein synthesis platform. - **Growth Signals**: - Up to $1 billion commitment to expanding U.S. manufacturing with a new facility in North Carolina. - VAX-31 Phase 3 program (OPUS-1, OPUS-2, OPUS-3) topline data expected Q4 2026 – H1 2027. - Headcount growth: actively hiring across 100+ roles (Analytical, Commercial, Clinical, Conjugation, Quality, Regulatory). - Recognized as a Great Place to Work and Best Workplace in BioPharma (multiple years). ## Competitive Advantages - **Broadest-spectrum PCV candidates**: VAX-31 is the broadest-spectrum pneumococcal conjugate vaccine in the clinic, targeting up to 31 serotypes. - **Differentiated platform**: Cell-free protein synthesis allows for the creation of complex, high-fidelity vaccines that can overcome bacterial defense mechanisms (e.g., capsule-switching) that limit conventional cell-based vaccines. - **Carrier-sparing technology**: Site-specific conjugation enables a higher valency (more serotypes) without compromising immunogenicity or tolerability. - **Manufacturing scale**: Significant investment in U.S.-based production capacity provides a long-term supply chain advantage and aligns with "Investing in America" initiatives. ## Strategic Focus - **Primary**: Advance VAX-31 and VAX-24 through late-stage clinical trials to secure regulatory approval and establish a new standard of care for pneumococcal disease. - **Pipeline expansion**: Advance VAX-A1 (Group A Strep) and VAX-GI (Shigella) candidates through early clinical development. - **Manufacturing**: Scale up internal manufacturing capabilities to support commercial launch and global supply. - **Commercial readiness**: Building a commercial organization (e.g., hiring a VP of U.S. Market Access & Pricing, Senior Director of Product Launch) to prepare for potential VAX-31 launch. ## Why Work Here - **Culture**: Described as a "kindness-first" mindset with a focus on audacious goals, collaboration, and mutual support. Recognized as a *Great Place to Work* and *Best Workplace in BioPharma* (Fortune). - **Work Model**: Hybrid, Remote, and Onsite options available depending on role. San Carlos HQ offers a hybrid schedule. - **Total Rewards**: 100% paid health, dental, and vision insurance; 401k matching; flexible PTO and holidays; paid parental and sick leave; equity awards (stock options & RSUs); Employee Stock Purchase Plan; lifestyle spending account; mental health and wellness resources. - **Growth & Development**: Strong emphasis on learning culture, professional advancement through coaching, and career development programs. - **Mission-driven**: Employees are directly contributing to creating vaccines that protect every child born and every adult at risk from bacterial infections globally. ## Sources 1. [vaxcyte.com](https://vaxcyte.com/) 2. [vaxcyte.com/careers](https://vaxcyte.com/careers/) 3. [vaxcyte.com/job-listings](https://vaxcyte.com/job-listings/) 4. [vaxcyte.com/culture](https://vaxcyte.com/culture/) 5. 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