The role includes preparing the organization for future structured data submission requirements — such as Veeva Registrations, IDMP readiness, and eCTD 4.0 — and collaborating across Regulatory Affairs, Clinical Development, Quality, Information Sciences (IS), IT, and other functions to establish integrated global processes. Bachelor’s degree in a life science, technical, or related field with 14+ years of experience in the biotechnology, pharmaceutical, or medical device industry, with at least 7 years focused on Regulatory Affairs/Operations and Veeva RIM systems (administration, configuration, and optimization).