Manager, Regulatory Information Management

Apellis Pharmaceuticals, Inc. seeks a Manager, Regulatory Information Management in Waltham, MA. The position may require working at additional unanticipated worksites throughout the U.S. The Manager will be responsible for planning, directing, or coordinating production activities to ensure compliance with regulations and standard operating procedures. This includes leading the implementation and management of a comprehensive data governance model and master data management based on current and emerging health authority requirements and data standards. The role involves managing end-to-end regulatory data/information within the company's systems, providing oversight for data completeness, curation, quality, data standards, reporting, and analytics. The Manager will lead data mapping, enrichment, data entry, and migration to Regulatory Information Management Systems (RIMS). Additionally, the position requires managing comprehensive global change requests for RIMS, regulatory reports, and dashboards used by internal and external stakeholders, while recommending enhancements and improvements. The Manager will support the implementation of a RIM system, including defining requirements, process mapping, obtaining stakeholder input, and maintaining the product lifecycle in the system. The role also involves assisting the RIM lead in developing a Regulatory Information systems landscape and related roadmap, as well as managing the development of training materials, quick reference guides, FAQs, job aids, and other reference documents that describe system-related business processes. Active participation in design and validation activities for the implementation of RIMS, including electronic Regulatory Document Management System (EDM), is also required.