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We invested in new offices, sector teams and practice groups including higher education; foundations and nonprofits; investor engagement; shareholder activism; governance; regulatory and public affairs, including geopolitical; crisis; litigation; social issues including climate change and diversity, equity and inclusion; cybersecurity, data and privacy; employee engagement; digital communications; opinion research and analysis, and; creative services.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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QUALIFICATIONSA scientific degree with directly relevant professional experience in small molecule product 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. Demonstrated track record in defining innovative CMC regulatory strategies, and implementing at a platform level.
$237,660 - $307,560ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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To do these effectively, the Analyst III – Policy & Regulatory Operations must have a demonstrated understanding of IEHP business operations and responsibilities of various departments in Health Services, Quality Systems, Provider Services, and Member Services; subject matter expertise of these departments’ policies and procedures and the regulations that drive their business operations and demonstrated ability to effectively and consistently manage multiple projects and priorities concurrently.
$80,059.2 - $106,059.2 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Providing overall leadership and direction to the Quality Assurance and Regulatory Affairs McKesson 3PL Team. The Senior Director, QARA is principally responsible for the development and implementation of the Company’s quality assurance program through the development and implementation of quality assurance and compliance standards via policies and procedures, training, auditing and monitoring, facilitating internal reporting, compliance-related investigations, and keeping Third Party Logistics VP of Quality Assurance & Regulatory Affairs informed on quality assurance and regulatory affairs matters.
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You will represent the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams (commercial, clinical development, delivery, quality, etc.) Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in various stages of development.
$169,400 - $266,200 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience with the dynamic regulatory landscape, especially in CMC and quality aspects. Experience in providing regulatory CMC strategy for submission of clinical trial application (IMPD/IND) and marketing authorization application (NDA/MAA) for small molecule development compounds, including chemical drug, peptide and oligonucleotide.
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Job DetailsThe 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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Develop the profile of the global Regulatory and IPMT practice group - this includes the practice areas of Antitrust and Competition; Communications, Internet, and Media; Energy Regulatory; Government Relations and Public Affairs; International Trade and Investment; Pharmaceuticals and Biotechnology Regulatory; and Privacy and Cybersecurity.
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POSITION OVERVIEW: The Regulatory Affairs, Accreditation & Safety Specialist (RASS) provides regulatory and safety expertise as related to Joint Commission, CMS, Oregon Health Authority, Pharmacy Board, OSHA, and other regulatory agencies.
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I-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Quality Assurance and Bioinformatics. You will provide technical support for the manufacturing equipment; investigations, continuous process improvements, change controls, and client onboarding.
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A thorough understanding of the complex Regulatory, Development and Medical Affairs requirements in oncology, as well as the emerging paradigm for cell & gene therapy. Precigen is advancing an exciting pipeline of novel cell and gene therapy products and to further our efforts we are seeking an Executive Director, Medical Affairs who will be instrumental in creating and building the global medical affairs function at Precigen for our first commercial launch.
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Works with the Regulatory Affairs, Accreditation & Safety Manager to convene various QI and Safety committees and work groups, set agenda to drive desired meeting outcomes (based on contract and accreditation requirements), and ensure proper recording of committee activities.
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The Change Control Specialist serves as a Subject Matter Expert (SME) and Owner in the performance/management of Quality Systems Change Control. Collaborate with cross functional teams during change control review boards, QIT's, planning meetings to achieve quality and compliance goals, representing manufacturing change control team.
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Experience being responsible for quality control of all scientific data generated within the Nonclinical Pharmacology group. · This position is responsible for the quality control of all nonGLP data generated in the Nonclinical Pharmacology group within GNAT unit of client.
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Duties include participating in a 24-hour standby rotation, performs Gas Control supervision and/or Gas Controller duties as needed while following change management protocols for CRM related processes and procedures to ensure compliance.
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regulatory affairs change control jobs Title: quality engineer
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