FUJIFILM Biotechnologies
Regulatory Affairs Specialist II
FUJIFILM Biotechnologies, College Station, Texas, United States, 77840
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Regulatory Affairs Specialist II
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FUJIFILM Biotechnologies The Regulatory Affairs Specialist II is responsible for supporting Regulatory Intelligence deliverables, the electronic publishing of regulatory submissions for national and regional regulatory agencies, and FUJIFILM Biotechnologies partner companies. The primary focus is on moderate to complex regulatory submissions in both eCTD and non-eCTD formats and working with site functional groups on responses to changes in Regulatory Intelligence. Actual work assignments are based on the FUJIFILM Biotechnologies portfolio of work, the incumbent's experience, knowledge, demonstrated technical skills and competencies, or as part of an individual development plan. The Regulatory Affairs function supports all FUJIFILM Biotechnologies Texas-related regulatory affairs activities for FUJIFILM Biotechnologies partner companies’ products, summarizes regulatory intelligence, provides regulatory-compliance input for regulatory submissions, and manages the FUJIFILM Biotechnologies Texas response to changes in the regulatory landscape. Overview
The work we do at FUJIFILM Biotechnologies Texas is important, and we are looking for passionate, mission-driven people 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. If you’re ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and cultivate a culture that fuels your passion, energy, and drive—what we call Genki. Our facility is located in College Station, Texas, combining a small-town feel with vibrant culture and proximity to major hubs. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments. We are guided by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers Job Details
Reports to
Director, Regulatory Affairs Work Location
College Station, TX Primary Responsibilities
Obtain data/documents from multiple internal teams for exchange and/or communication with FUJIFILM Biotechnologies partner companies. Upload information to the Regulatory documentation management location for future use. 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. Produce and manage the generation of documentation to be submitted to worldwide governmental regulatory agencies to secure approvals for products manufactured and/or distributed by FUJIFILM Biotechnologies partners. 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. 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. Maintain proficiency on regulatory requirements; and FDA/Notified Body published reviews as applicable. 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 and appropriate actions are taken by the respective stakeholders. Be responsible for ensuring personal and Company compliance with all Federal, State local, and Company regulations, policies, and procedures. May support the review and negotiation of Master Service Agreements (MSA) and Quality Agreements (QAg). Qualifications
Bachelor's degree from accredited university with 1+ year of GMP working experience. Associate degree from accredited university with 3+ years of GMP working experience. Working knowledge of Regulatory Information Systems, planning and/or publishing tools. Working knowledge of and experience with various submission and application types, publishing templates and relevant regulatory agency and industry guidelines. Effective interpersonal, teamwork, networking, and communication skills. Proficiency in applying submission-readiness and publishing standards via Adobe Acrobat, MS Word and related applications. Proficiency with various aspects of the PQS, specifically Change Controls, CAPAs, Deviation Management. Demonstrated ability to build productive relationships across an organization and with FUJIFILM Biotechnologies partner companies. Problem-solving capability, including troubleshooting and adaptability required. Understanding of the drug development process. Skill to apply knowledge of submission-readiness and publishing standards. Cell & Gene Therapy area and product knowledge, strong understanding of product development process. Fluency in English, proofreading and strong negotiation skills. Ability to work or lead in a matrix environment and execute assignments independently. Strong organization, written and verbal communication skills. Demonstrated ability to handle multiple competing priorities. Role model for company core values of trust, delighting customers, and Gemba. Physical Requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to: Experience prolonged standing, some bending, stooping, and stretching. Ability to sit for long periods to work on a computer. Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials. Ability to wear personal protective equipment including safety glasses, lab coat, gloves, and other required attire. Lifting to 25 pounds on occasion. Use hand-eye coordination and manual dexterity to operate office equipment. Must be willing to work flexible hours and weekends or off-shift hours as needed. Must be willing to travel occasionally. Attendance is mandatory. EEO Information: Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, national origin, disability, veteran status, etc. ADA Information: If you require reasonable accommodation in completing this application or participating in the selection process, please contact our HR Department at FDBTHR@fujifilm.com or (979) 431-3500.
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Regulatory Affairs Specialist II
role at
FUJIFILM Biotechnologies The Regulatory Affairs Specialist II is responsible for supporting Regulatory Intelligence deliverables, the electronic publishing of regulatory submissions for national and regional regulatory agencies, and FUJIFILM Biotechnologies partner companies. The primary focus is on moderate to complex regulatory submissions in both eCTD and non-eCTD formats and working with site functional groups on responses to changes in Regulatory Intelligence. Actual work assignments are based on the FUJIFILM Biotechnologies portfolio of work, the incumbent's experience, knowledge, demonstrated technical skills and competencies, or as part of an individual development plan. The Regulatory Affairs function supports all FUJIFILM Biotechnologies Texas-related regulatory affairs activities for FUJIFILM Biotechnologies partner companies’ products, summarizes regulatory intelligence, provides regulatory-compliance input for regulatory submissions, and manages the FUJIFILM Biotechnologies Texas response to changes in the regulatory landscape. Overview
The work we do at FUJIFILM Biotechnologies Texas is important, and we are looking for passionate, mission-driven people 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. If you’re ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and cultivate a culture that fuels your passion, energy, and drive—what we call Genki. Our facility is located in College Station, Texas, combining a small-town feel with vibrant culture and proximity to major hubs. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments. We are guided by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers Job Details
Reports to
Director, Regulatory Affairs Work Location
College Station, TX Primary Responsibilities
Obtain data/documents from multiple internal teams for exchange and/or communication with FUJIFILM Biotechnologies partner companies. Upload information to the Regulatory documentation management location for future use. 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. Produce and manage the generation of documentation to be submitted to worldwide governmental regulatory agencies to secure approvals for products manufactured and/or distributed by FUJIFILM Biotechnologies partners. 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. 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. Maintain proficiency on regulatory requirements; and FDA/Notified Body published reviews as applicable. 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 and appropriate actions are taken by the respective stakeholders. Be responsible for ensuring personal and Company compliance with all Federal, State local, and Company regulations, policies, and procedures. May support the review and negotiation of Master Service Agreements (MSA) and Quality Agreements (QAg). Qualifications
Bachelor's degree from accredited university with 1+ year of GMP working experience. Associate degree from accredited university with 3+ years of GMP working experience. Working knowledge of Regulatory Information Systems, planning and/or publishing tools. Working knowledge of and experience with various submission and application types, publishing templates and relevant regulatory agency and industry guidelines. Effective interpersonal, teamwork, networking, and communication skills. Proficiency in applying submission-readiness and publishing standards via Adobe Acrobat, MS Word and related applications. Proficiency with various aspects of the PQS, specifically Change Controls, CAPAs, Deviation Management. Demonstrated ability to build productive relationships across an organization and with FUJIFILM Biotechnologies partner companies. Problem-solving capability, including troubleshooting and adaptability required. Understanding of the drug development process. Skill to apply knowledge of submission-readiness and publishing standards. Cell & Gene Therapy area and product knowledge, strong understanding of product development process. Fluency in English, proofreading and strong negotiation skills. Ability to work or lead in a matrix environment and execute assignments independently. Strong organization, written and verbal communication skills. Demonstrated ability to handle multiple competing priorities. Role model for company core values of trust, delighting customers, and Gemba. Physical Requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to: Experience prolonged standing, some bending, stooping, and stretching. Ability to sit for long periods to work on a computer. Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials. Ability to wear personal protective equipment including safety glasses, lab coat, gloves, and other required attire. Lifting to 25 pounds on occasion. Use hand-eye coordination and manual dexterity to operate office equipment. Must be willing to work flexible hours and weekends or off-shift hours as needed. Must be willing to travel occasionally. Attendance is mandatory. EEO Information: Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, national origin, disability, veteran status, etc. ADA Information: If you require reasonable accommodation in completing this application or participating in the selection process, please contact our HR Department at FDBTHR@fujifilm.com or (979) 431-3500.
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