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Minimum of 5 years of experience as a Developer/Business Systems Analyst with a focus on QMS in the medical device industry, including expertise in Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
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Collaborate with onshore teams and stakeholders to gather business requirements related to QMS functionalities, with a focus on Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
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Requirements Gathering and Analytics:Partner with onshore teams and stakeholders to gather business requirements related to QMS functionalities, with a focus on Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
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Director, CMC Regulatory Affairs – Biologics. Associate Director, Regulatory Affairs Advertising and Promotion page is loaded. Associate Director, Regulatory Affairs, Labeling.
$177,905 - $230,230Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Director, CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio. A scientific degree with directly relevant professional experience in biologics development, global CMC regulatory affairs, and CMC technical areas of at least 12 years with a BA/BS or 10 years with an MA/MS, PhD, PharmD, or MD.
$205,700 - $266,200 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Develop and implement Data Loss Prevention (DLP) policies specifically for Fabric and Power Platform connectors to safeguard sensitive data and ensure compliance with legal and regulatory standards.
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The Field Safety Professional is responsible for ensuring compliance with all regulatory requirements, owner requirements and company policies/procedures on site while being part of a team that will create and cultivate an injury and accident-free work environment.
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The Senior Manager, Regulatory Affairs CMC, is responsible for providing regulatory guidance on Chemistry, Manufacturing and Controls (CMC) regulatory activities for assigned product(s) in coordination with key internal stakeholders.
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The successful candidate has experience in drug-development process, clinical study lifecycle, regulatory compliance, and the uses of real world evidence in clinical development and safety endeavors.
$221,170 - $286,220 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Gordon Li, M.D. Professor of Neurosurgery and Search Committee Chair Department of Neurosurgery Stanford University c/o Phil Pajar, Faculty Affairs Administrator email: pajar@stanford.edu The expected base pay range for this position is: Rank Assistant: $340,000-$358,000 Rank Associate: $400,000-$418,000 Rank Professor: $460,000-$472,000 This pay range reflects base pay, which is based on faculty rank and years in rank.
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VP of Government Relations & Public Affairs. Apeksha Kumavat, Gatik Chief Engineer & Co-founder Recognized on the Inc. 2022 Female Founders 100 List. Gautam Narang, Gatik CEO & Co-founder, Named as 2021 Automotive News All-Star.
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Support Director of Regulatory Operations with publishing, RIM maintenance. Experience supporting a wide array of Regulatory Submissions (IND/CTA through NDA/MAA) They are looking for a Manager or Senior Manager of Regulatory Operations to join their team.
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They are accountable for execution of all applicable risk programs (Credit, Market, Financial Crimes, Operational, Regulatory Compliance), which includes effectively following and adhering to applicable Wells Fargo policies and procedures, appropriately fulfilling risk and compliance obligations, timely and effective escalation and remediation of issues, and making sound risk decisions.
$207,900 - $431,900 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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In this position, you will work closely with the Process Development, Quality Control, Analytical Operations, Quality Assurance, Translational Medicine, Biometrics, and Regulatory team members and will contribute to flow cytometry-based assay development for product understanding of CARGO Therapeutics’ pipeline candidates, method transfer and/or qualification, SOP/technical report authoring and review, method life cycle management, data analysis, and execution of routine analytical testing.
$100,000 - $138,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Plan, develop, and execute relevant bench-top, pre-clinical and cadaver studies as needed for regulatory, clinical and R&D requirements. Develop and execute processes in alignment with all regulatory and quality standards.
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regulatory affairs jobs Title: sr director Company: Merck in Menlo Park, CA
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