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Director, Regulatory Compliance
Forge Biologics
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Columbus, OH
... About The Team The Regulatory Affairs department plays a critical role in ensuring that our products meet regulatory standards and compliance requirements to deliver safe and effective gene therapy solutions to patients. As a central hub for ... - May 07
Regulatory Project Coordinator - Regulatory Affairs Administration
Nationwide Children's Hospital
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Columbus, OH
... Regulatory Project Coordinator coordinates the processing, reporting, and special projects for the Office of Research Regulatory Affairs. This position is responsible for maintaining relevant records through the database, and preparing reports on FDA ... - Apr 30
Regulatory Project Coordinator - Regulatory Affairs Administration
Nationwide Children's Hospital
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Columbus, OH, 43215
... Regulatory Project Coordinator coordinates the processing, reporting, and special projects for the Office of Research Regulatory Affairs. This position is responsible for maintaining relevant records through the database, and preparing reports on FDA ... - Apr 29
Research/Regulatory Nurse Practitioner - Gene Therapy
Nationwide Children's Hospital
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Columbus, OH
... research patient management activities, specifically related to regulatory work, in conjunction with the Clinical Research ... staff, assists in the writing of FDA Annual Reports, OBA reporting, preparation of DSMB reports, and Clinical Study Reports. ... - Apr 17
Research/Regulatory Nurse Practitioner - Gene Therapy
Nationwide Children's Hospital
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Columbus, OH, 43215
... research patient management activities, specifically related to regulatory work, in conjunction with the Clinical Research ... staff, assists in the writing of FDA Annual Reports, OBA reporting, preparation of DSMB reports, and Clinical Study Reports. ... - Apr 16
Associate Specialist, EMEA Product Regulatory Compliance - A&F Co
Abercrombie & Fitch Co.
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Columbus, OH, 43216
Company Description Job Description Partner closely with regulatory service providers to stay apprised of all emerging regulations in the EMEA region to ensure product testing, labeling, registration and overall compliance strategies support A&F's ... - May 11
Regulatory Affairs Intern
American Regent Laboratories
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New Albany, OH, 43054
... functions in relation to regulatory affairs. * Responsible for assisting the regulatory team in the creation and maintenance of CMC and labeling submission content. * Data review and remediation of CMC and labeling documentation. * Uploading FDA ... - May 07
Packaging Manager
Battle Green
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Columbus, OH
... ensuring equipment reliability, accurate product labeling, and pristine product handling. Simultaneously, you'll drive continuous improvement initiatives and maintain adherence to all regulatory and internal standards, ensuring that our products ... - Apr 26
Sr Computer System Validation (CSV) Engineer
Forge Biologics
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Columbus, OH
... in partnership with functional teams, ensuring the documentation meets regulatory requirements and quality standards. ... for Pharmaceutical Engineering (ISPE) guidelines such as GAMP 5, FDA Data Integrity guidelines, 21 CFR Part 11 and Annex 11 ... - May 01
Director of Manufacturing
ACE Partners
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Columbus, OH, 43224
... the production process to ensure compliance with regulatory reporting standards and facilitate product recalls if necessary. ... compliance with FDA, ISO, and Quality System requirements, as well as safety standards. manufacturing-related audit findings ... - May 12