Manager I, Regulatory Affairs Operations

Role: Regulatory Affairs Operations Manager supporting document management and submission processes. Responsibilities: manage Veeva Vault RIM content plans, coordinate regulatory submissions, archive correspondence, ensure compliance with regulatory requirements, support project tracking, and assist in team development. Requirements: bachelor’s in science or health discipline; 5+ years in regulatory operations with expertise in publishing/submissions management and records; proficiency in Veeva RIMS, eCTD templates, and related tools; strong understanding of FDA, EMA, ICH regulations; excellent organizational, communication, and analytical skills; ability to work independently and handle multiple projects. High-Value: focus on regulatory submissions (NDA, IND, MAA, CTA), eCTD, FDA/EMA guidelines, Veeva Vault RIM, regulatory document management, project coordination. Work setup: hybrid Irvine; some travel up to 20%.