Associate Director, Regulatory CMC

🔥 6 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $180k - $210.5k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Vaxcyte

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2013

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

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

• Leads the preparation and review of CMC sections of global regulatory submissions, as well as the interactions and responses with regulatory agencies • Member of technical development teams which require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance • Defines CMC content (data and documentation) requirements for regulatory submissions and compiles/reviews this content for conformance with established requirements • Provides CMC regulatory guidance to cross-functional teams and key stakeholders • Manages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations throughout development • Leads projects with cross-functional teams and acts as the primary regulatory CMC contact for assigned products and projects • Represents company in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters • Stays abreast of current and evolving regulatory CMC requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development • Participates in the design, development and implementation of department strategies, providing recommendations in area of expertise

🎯 Requirements

• Bachelor’s Degree in a scientific discipline (e.g. Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices) • Minimum 10 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 • Post-approval supplements/variations highly preferred • INDs/IMPDs • Prior development or manufacturing experience is a plus • 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 • Excellent interpersonal skills to communicate difficult concepts • Strategic thinking and strong problem-solving skills • Collaborates and communicates in an open, clear, complete, timely, and consistent manner • Strong sense of planning and prioritization, and the ability to work with all levels of management • Advanced knowledge in regulatory (FDA, EMA, Health Canada and ICH) guidelines.

🏖️ Benefits

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