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10+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs / small molecules.
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The Director of Regulatory and Quality leads both regulatory and quality functions for the CTP. This position is responsible for managing Regulatory and Quality functions, developing Systems to ensure compliance with sponsored clinical trials standards and regulations, including 21 CFR Parts 11, 312 and 812.
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The Own Brands Technical Services team has an opening for a Regulatory Affairs Associate. As part of the Regulatory Affairs team, the RA Associate will be responsible for ensuring faultless compliance of product labeling for several brands within Albertsons Own Brands.
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Develops, reviews, strengthens, and approves all CTP-controlled documents including policies, SOPs, validation documents, change control, deviations and CAPAs∯*∯ ● Develops, plans, and leads readiness for inspections and audits at CTP by GCP and GxP regulatory authorities, clinical investigator sites, and contract organizations.
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Principal Regulatory Affairs Specialist- Software & Artificial Intelligence (U.S. Hub Based) The Principal Regulatory Affairs Specialist- SW & AI will shape, lead and execute innovative regulatory strategies to drive innovation within the Philips Innovation and Strategy organization globally.
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Assists the Lead and Department in maintenance of equipment and QA/QC program(s) for meeting regulatory and accreditation and re-accreditation. Associate's: Higher Other: Completion of an Accredited Radiology Technology Program CERTIFICATION & LICENSURE ARRT - Radiography - American Register of Radiologic Technologists CRT-Certified Radiologic Technologist CT-Computed Tomography within 1 Year of hire RHF-Radiology Fluoroscopy within 1 Year of hire BLS-Basic Life Support Healthcare Provider RHM-Radiology Mammography, where applicable JCERT approval for Student Site Coordinator.
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As a Senior Water Resources Engineer at Terraphase, you will play a critical role in developing and implementing water resource projects, ensuring compliance with regulatory standards, and addressing complex water-related issues.
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Reporting directly to the Vice President, Information Technology Services and Operations the successful candidate will play a pivotal role in safeguarding our sensitive data, protecting our digital assets, and ensuring regulatory compliance across all aspects of our operations.
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As a Regulatory Affairs Project Manager you will have the opportunity to work with internal and external teams for project/product realization, write and prepare submission packets for health authority marketing approvals, and utilize agile principles to drive regulatory activities for our Companion Diagnostics Group (CDx.
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We are seeking a Principal Regulatory Affairs Specialist to join Abbott's Heart Failure Division on-site in Pleasanton, CA. As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment.
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Represents Regulatory Affairs on cross-functional product development and manufacturing support teams. Regulatory Affairs Certification (RAC) is a plus. Coordinates, compiles, and submits regulatory submissions, including European Dossiers, Premarket Notifications, PMA Supplements, Change Notifications, and other country-specific product registrations.
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Collaborate closely with cross-functional teams and key stakeholders (Study Management, Site Engagement & Monitoring Excellence, Clinical Sciences, Regulatory Operations, Clinical Supply, Legal and Finance) to develop and execute study start-up plans in alignment with project timelines and objectives.
$148,000 - $161,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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For the health and safety of our team members and residents, Oakmont Management Group may require team members to vaccinate, participate in daily screening, surveillance testing, and to wear face coverings and other personal protective equipment (PPE) to prevent the spread of the COVID-19 or other communicable diseases, per regulatory guidelines.
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This includes SAE quality check (QC), late case investigations, corrective and preventive actions (CAPA), distribution and regulatory submissions in a timely fashion to ensure compliance with local and global regulatory reporting.
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This position requires partnership with Supply Chain, QA/QC, Manufacturing, Packaging, Engineering, Finance, and Regulatory Affairs to implement new processes and manage changes. Promote Safety, 6S Culture, and ensure Regulatory Compliance (FTZ, OSHA, CTPAT.
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regulatory affairs jobs Title: regulatory affairs assistant Company: Jobget in Union City, CA
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