Vaxcyte - Associate Director, SEC Reporting & Technical Accounting

• BA or BS in a relevant scientific or technical discipline, i.e., clinical pharmacology, immunology, biology, medicine, bioanalytics or related life sciences, is required with 15+ years industry experience that demonstrates technical and regulatory expertise and competence.  Graduate education and/or professional certifications or training in regulatory and/or quality are a bonus. Other combinations of education and/or experience may be considered • 10+ years of extensive and relevant regulatory experience with a proven record of achievement in developing and prosecuting regulatory submissions and application approvals within the pharmaceutical or biotechnology industry with a particular emphasis on vaccines and clinical content. • A thorough understanding of clinical development, statistics with particular experience with vaccine development and commercialization. • Direct experience engaging multiple health authorities, i.e., FDA, EMA, MHRA, Health Canada, etc., and preparation of regulatory applications for global health authorities. • Demonstrated ability to lead and manage cross-functional teams, developing and establishing regulatory strategies and preparing regulatory applications including review and submission of clinical and pre-clinical documentation to regulatory authorities. • Direct experience developing clinical regulatory strategies and submissions to effectively manage labelling for global markets and post-approval changes and optimizations for commercial vaccines. • Demonstrated record identifying clinical and regulatory risks and developing strategies and/or contingencies for mitigation. • Experience translating and integrating contemporary regulatory intelligence into appropriate internal policies and practice. • Articulate oral and written communication skills • Active listening • Strategic and tactical critical thinking • Constructive operational productivity • Flexible and optimistic demeanor • Reports to: SVP, Regulatory Affairs • Reports to: • Location: Remote - US • Location: