Digital Chemistry, Manufacturing, and Controls (dCMC) is a cross-divisional digital transformation initiative that will enable the pipeline by establishing a digital continuum of data from development through manufacturing for our products and processes. dCMC intends to deliver: Increased productivity and speed to clinic/market Accelerated timelines for site, filing, and launch readiness Improved access to product and process data Streamlined transfer of process and product knowledge with reduced error rates A key enabler of these outcomes is implementation of digital solutions that will install the foundational capabilities needed to realize dCMC's vision of frictionless flow of data from development to commercialization and supply. A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a frictionless flow of data from source systems to regulatory documentation. Under the guidance of dCMC Regulatory Authoring Leadership, the Senior Specialist, Regulatory Authoring Business Analyst, will optimize regulatory authoring processes and enhance data management by mapping workflows, prioritizing source documents for digitization, and collaborating with cross-functional teams to implement digital solutions. The applicant will help define and implement the approach of structured content management. They will also support project management activities to ensure efficient execution and compliance within CMC operations.