Manager, Regulatory Information Management

Apellis Pharmaceuticals, Inc. seeks a Manager, Regulatory Information Management in Waltham, MA. May work at additional unanticipated worksites throughout the U.S.

Duties: Plan, direct, or coordinate production activities of the company to ensure compliance with regulations and standard operating procedures, including 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. Manage E2E Regulatory data/information within the company’s system(s). Provides oversight for data completeness, curation, quality, data standards, reporting and analytics. Lead data mapping, enrichment, data entry and migration to RIMS. Manage comprehensive global change request for RIMS (data model and functionality). Manage regulatory reports and dashboards used by internal and external stakeholders and recommend enhancements and improvements. Support the implementation of a RIM system for the company including defining requirements, process mapping, obtaining stakeholder input and maintaining the product lifecycle in the system. Assist RIM lead in the development of a Regulatory Information systems landscape and related roadmap. Manage and oversee development of training materials, ‘quick reference guides’, FAQs, Job Aids, and other reference documents, describing system related business processes. Actively participate in design and validation activities for the implementation of RIMS, including electronic Regulatory Document Management System (EDM).

Requires a Master’s degree in Biotechnology, Biology, Drug Regulatory Affairs, or a related field and 2 years of experience in job offered or a scientific/ technical occupation.

Requires 1 year of experience with each of the following: 1. Regulatory Affairs/Operations, and Regulatory information management within the pharmaceutical and medical device industry; 2. Data standards – IDMP, XEVMPD; 3. CTD/eCTD structure and requirements and submission requirements for global submission types; 4. R&D Systems; using Veeva Vault and other systems for regulatory document management, compliance, and data integration in regulatory and R&D environments. 5. Business analysis compliance, data quality activities and execute the implementation of and maintenance of a RIM system (RIMS). 6. Maintain and monitor end-to-end Regulatory data/information and contribute to analytics and reporting. 7. Enhance and improve information management capabilities to ensure data integrity and compliance.

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