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Director of Risk Management & Regulatory Affairs ( Patient Safety Officer / Privacy Officer ) The Director of Risk Management and Regulatory Affairs (Patient Safety Officer/Privacy Officer) serves as an accessible resource to the hospital and community on risk management and regulatory issues.
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May oversee and direct the work of other Regulatory Affairs professionals. Serves as a regulatory liaison for new product development and make regulatory assessments of proposed changes to existing products for impact to regulatory documentation.
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Facilitates alternative forms (i.e., mediation, restorative justice) of dispute resolution, when appropriate, and consult with the Dean of Students, Title IX Coordinator, and legal counsel regarding complex higher education legal and regulatory issues.
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15+ 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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As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals Oligonucleotide regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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Ability to create procedures to interpret and align with regulatory policies, while enabling investigators perform appropriate level of due diligence. To be successful in this role, you must have a demonstrated ability leading a global trade compliance function, with a special focus on economic sanctions and foreign trade laws.
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Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
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Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art class III cardiovascular medical devices. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.
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Concords Business & Legal Affairs team is comprised of 40+ professionals who provide business and legal affairs support to Concords three primary divisions: Recorded Music, Music Publishing, and Theatricals.
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Concord is seeking law students who are currently 1L or 2L students at ABapproved law schools for paid summer 2024 internships in the Business & Legal Affairs Department. Students who are selected for these internships will have the opportunity to participate in a variety of business and legal affairs matters in each of Concords divisions.
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Plumbing Inspector: Applicants must possess a valid license as a Plumbing Inspector of the appropriate level, High-Rise and Hazardous (HHS) or Industrial and Commercial (ICS), issued by the New Jersey Department of Community Affairs.
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Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
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The EA organization comprises CRA Strategy & Program Management, Government & Policy Affairs, Regulatory Relations, Corporate Communications, Community Finance, Community Impact & Investment, and EA Strategy & Engagement.
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Authorized User: As defined in part by the Nuclear Regulatory Commission, an individual who has completed a minimum of 700 hours of training in a structured educational program consisting of both didactic training and supervised on the job training in radiation physics, instrumentation, radiation protection, chemistry, math and radiation biology.
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Regulatory affairs experience in the medical device industry with a track record of successful submissions. Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance.
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regulatory affairs jobs Title: regulatory affairs associate Company: Cardinal Health
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