Quality Assurance - Regulatory Affairs CMC Associate II
Company: FUJIFILM Holdings America Corporation
Location: College Station
Posted on: March 17, 2023
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB) -The work we do at FDB has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki.Summary: -The Regulatory Affairs CMC Associate II is responsible for supporting the electronic publishing of regulatory submissions for national and regional regulatory agencies, and FUJIFILM Diosynth partner companies. The primary focus of this position is on moderate to complex regulatory submissions in both eCTD and non-eCTD format. Actual work assignments are based on the FUJIFILM Diosynth portfolio of work along with the incumbent's experience, knowledge, demonstrated technical skills, and competencies, or as part of an individual's development plan.Regulatory Affairs supports all CMC regulatory affairs activities for FUJIFILM Diosynth partner companies' products, summarize regulatory intelligence, provides CMC regulatory input for regulatory submissions, and manages the compilation and SME review of CMC sections of all submissions for completeness and quality.
Keywords: FUJIFILM Holdings America Corporation, College Station , Quality Assurance - Regulatory Affairs CMC Associate II, Other , College Station, Texas
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