Hiring: Associate Director, Regulatory CMC Company: Vaxcyte Location: San Carlos, CA Job Posted Time: 2026-09-10 10:36:35 Employment Type: Remote About the job Experience: •10 years of experience working in vaccine or biotech industry, or in a related field, or the equivalent combination of education and experience. Other combinations of education and/or experience may be considered. •Minimum 10 years of experience working in vaccine or biotech industry, or in a related field, or the equivalent combination of education and experience. Other combinations of education and/or experience may be considered. Required Skills: •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 Qualifications: •Prior development or manufacturing experience is a plus. •Computer software skills (LIMS, SAP, TrackWise, Veeva will be used). •Demonstrated capacity 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 Compensation: •$180,000 - $210,500 / year •Competitive benefits and rewards package •The compensation package will be competitive and includes comprehensive benefits and an equity component Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!