Senior Specialist, Digital CMC Regulatory Authoring Data Analyst

Job Description

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.

The responsibilities of the dCMC Business Analyst include: 

• Business Process Mapping and Optimization: Working with Digital CMC and associated business stakeholders, the analyst will map end-to-end processes that produce regulatory authoring data, convert complex tasks into clear workflows, identify gaps, and prioritize solutions to improve efficiency and compliance.

• Source Document Identification and Prioritization: The analyst will identify true source documents for past regulatory filings to prioritize digitization and integration. They will drive decisions in collaboration with the data strategy team on areas of priority and opportunities for further investment.

• Stakeholder Management & Communication: The analyst will organize and lead information gathering sessions with the internal CMC community, collaborate with cross-functional teams to gather business requirements, and coordinate with IT, Research, and Manufacturing to capture feedback on developed capabilities to ensure effective digital solution integration and adoption.

• Documentation and Project Management Support: The analyst will create detailed process documentation, including workflows and data models. They will support project management by tracking tasks, reporting status, coordinating meetings, managing timelines and risks, and monitoring KPIs to measure digitization success.

• Application SME and Data Steward: The analyst will support application deployment and use, with responsibilities ranging from data template creation and maintenance, onboarding data stewards from the business, authoring SOPs for new application releases, and troubleshooting use and data management. 

Required Skills and Experience:

• Knowledge of manufacturing, testing, quality, and supply chain processes from late clinical development through commercialization, with practical insight into how these operations generate CMC regulatory content

• Understanding of CMC operations, technology transfer, control strategy development, and regulatory authoring requirements that inform automated filing generation

• Hands-on experience in regulatory authoring and submission documentation, including preparing, reviewing or supporting filing ready content and structured filing outputs.

• Proven ability to map business processes, perform gap analyses, and redesign workflows to improve efficiency, reduce errors, and enable digitization.

• Experience in digitization and data management initiatives in regulated environmen