Backed by 500 Global.
About the role
The work we do at FUJIFILM Biotechnologies Texas has never been more important—and we are looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.
What they're looking for
- Regulatory experience in a pharmaceutical or regulated industry,
- GMP/GXP or a comparable heavily regulated environment,
- Regulatory Information Systems, planning and/or publishing tools
More about this role
Job Title: QA Supervisor – Regulatory Affairs
Job Description: QA Supervisor – Regulatory Affairs for FUJIFILM Diosynth Biotechnologies Texas LLC, Bryan, TX. Responsible for supporting the electronic publishing of regulatory submissions for national and regional regulatory agencies, and FUJIFILM Diosynth partner companies with the primary focus on moderate to complex regulatory submissions in both eCTD and non-eCTD format. 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. (25%). Specific job duties include the following: Obtain data/documents from multiple internal teams for exchange and/or communication with FUJIFILM Diosynth partner companies. Upload information to the Regulatory documentation management location for future use.( 25%) May be required to compile and report key information to pertinent stakeholders within the Quality team to ensure proper visibility and communication. Support a vibrant regulatory culture, working among...
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