FUJIFILM Biotechnologies
Regulatory Affairs Specialist II (On-site in College Station, TX)
FUJIFILM Biotechnologies, Granite Heights, Wisconsin, United States
Regulatory Affairs Specialist II (On-site in College Station, TX)
The Regulatory Affairs Specialist II is responsible for supporting the Regulatory Intelligence deliverables, the electronic publishing of regulatory submissions for national and regional regulatory agencies, and FUJIFILM Biotechnologies partner companies. The primary focus of this position is on moderate to complex regulatory submissions in both eCTD and non-eCTD format and working with site functional groups with their response to changes in relevant Regulatory Intelligence. Actual work assignments are based on the FUJIFILM Biotechnologies portfolio of work along with the incumbent's experience, knowledge, demonstrated technical skills, and competencies, or as part of an individual's 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. 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 marketing 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 is required. Problem-solving capability, including trouble shooting 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. Ability to execute assignments independently as assigned. Must possess strong organization skills, strong written and verbal communication skills. Demonstrated ability to handle multiple competing priorities simultaneously. Role model for company core values of trust, delighting our customers, and Gemba. Seniority level
Associate Employment type
Full-time Job function
Science and Administrative Industries
Biotechnology Research and Pharmaceutical Manufacturing
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The Regulatory Affairs Specialist II is responsible for supporting the Regulatory Intelligence deliverables, the electronic publishing of regulatory submissions for national and regional regulatory agencies, and FUJIFILM Biotechnologies partner companies. The primary focus of this position is on moderate to complex regulatory submissions in both eCTD and non-eCTD format and working with site functional groups with their response to changes in relevant Regulatory Intelligence. Actual work assignments are based on the FUJIFILM Biotechnologies portfolio of work along with the incumbent's experience, knowledge, demonstrated technical skills, and competencies, or as part of an individual's 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. 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 marketing 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 is required. Problem-solving capability, including trouble shooting 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. Ability to execute assignments independently as assigned. Must possess strong organization skills, strong written and verbal communication skills. Demonstrated ability to handle multiple competing priorities simultaneously. Role model for company core values of trust, delighting our customers, and Gemba. Seniority level
Associate Employment type
Full-time Job function
Science and Administrative Industries
Biotechnology Research and Pharmaceutical Manufacturing
#J-18808-Ljbffr