QA Supervisor Regulatory Affairs

Job Title: QA Supervisor Regulatory Affairs

Worksite: Bryan TX

Requisition #

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 functional groups as a teammate and collaborator to develop successful regulatory strategies.(10%). Produce and manage the generation of documentation to be submitted to worldwide governmental regulatory agencies to secure approvals for marketing products manufactured and/or distributed by FUJIFILM Diosynth partners. (15%) Support development teams working towards modifying existing processes or creating new processes; ensure compliance with existing design controls risk management and domestic and international regulations.(5%) Ensure timely approvals communicate and support negotiations with the FDA and other regulatory bodies as needed to identify pre-submission requirements and strategy and to resolve post-submission queries and issues.(5%) Maintain proficiency on regulatory requirements; and FDA/Notified Body published reviews as applicable.(5%) Provide continuing regulatory education and disseminate regulatory information to the product development marketing and clinical groups. Ensure that regulatory intelligence communications are disseminated in a timely manner to the appropriate business functions. (5%) Be responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures. Support the review and negotiation of Master Service Agreements (MSA) and Quality Agreements (QAg).(5%)

The work we do at FUJIFILM Biotechnologies Texas has never been more importantand we are looking for passionate mission-driven people like you who want to make a real difference in peoples 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.

If youre ready to help transform the future of medicine join FUJIFILM Biotechnologies. We offer a flexible work environment and were proud to cultivate a culture that will fuel your passion energy and drivewhat we call Genki.

Our state-of-the-art biomanufacturing facility is located in in College Station Texas which combines a small-town feel with vibrant culture top-notch schools and close proximity to big city life. Nestled between major hubs its a dynamic location that blends convenience with innovation.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description