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The Regulatory Specialist under the supervision of the Director of Accreditation and Regulatory Affairs has responsibility for site visit preparation, coordination of site visit logistics and response, as well as assist in preparing report-out to management of major regulatory changes and issues of mock or real survey results.
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The Regulatory Engineer will support the Compliance Manager in problem resolution between safety agencies and company. Represent company’s interests by participation in Standards Development Committees, and inform appropriate internal organizations of latest regulatory requirements.
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Researches energy policy and evaluates business impacts to ensure the company remains competitive under evolving federal and state regulatory environments. Experience with regulatory agencies including FERC and PUCs in AZ, CO, TX, NM. Criteria/Conditions: Position requires travel up to 25% of the time.
$118,000 - $165,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Director of Quality & Regulatory reports directly to the VP, Medical Affairs. Review audits and ongoing monitoring of DEA compliance, FDA compliance, PDMP compliance, OSHA compliance, HIPAA and HITECH compliance, and Boards of Pharmacy regulatory compliance, and compliance with client KPIs. Partner with the CCO to the design and maintenance of quality programs, including but not limited to QA plans, inspection procedures, work instructions, training, deviation investigations and CAPA management, facility mapping and validation projects.
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Risk | Trading Risk Management (TRM) | Regulatory Risk Manager | Location. Risk, Regulatory Risk Manager, NYC. Immediately escalate to senior management in case issues with any regulatory deliverables.
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Report to the Sr. Manager, Regulatory. The Regulatory Specialist Contractor provides technical expertise and support in food product labeling, nutrition, and regulatory guidance for Ferrara.
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Partner across CMC Regulatory Affairs, PDM, and other functional groups across Gilead for support with opportunities for regulatory innovation / promote the use of novel approaches within project teams to resolve issues and problems.
$295,290 - $382,140ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Analyst II, Regulatory Affairs has experience with and performs key centralized complex and difficult regulatory activities for the Compliance Department. Knowledge of and experience with state and Federal regulatory and other requirements and practices related to Covered California, Medicare and Medi-Cal (Medicaid), Title 19 (USC)/Title 29 (USC and CCR), Title 22 (CCR), Title 28 (CCR), Title 42 (USC and CFR), CA Welfare and Institutions Code, and CA Health and Safety Code.
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Scope of ResponsibilityWill serve as a key strategic partner representing Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to Biopharmaceutical and/or CGT R&D, Pharma Supply Chain, Clinical Trial Supply, Quality Assurance, and Commercial interfaces on both global project and key strategic business initiatives.
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The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager's gene therapy products.
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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 Companys 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.
$142,200 - $237,000 a yearExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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The Clinical Research Regulatory Project Manager position exists to support research divisions engaged in Contract Research Organization (CRO) activities as well as the conduct of clinical trials at a site level.
$30.55 - $44.3 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Senior Manager, Federal Regulatory Affairs will report to the Managing Director, Federal Regulatory Affairs and will be responsible for working with internal and external constituents to develop and advocate Federal energy regulatory and market policy positions on behalf of Constellation.
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This position will partner with Regulatory Affairs as the department brings publishing and submissions in-house. The Senior Manager/Manager Regulatory Document Submissions will report to the Director of Medical Writing, Regulatory.
$126,500 - $160,100 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Regulatory Affairs Manager *PC Regulatory Affairs - Waltham MAAt Miltenyi Biotec, 3, employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies.
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regulatory job Title: regulatory affairs project manager Company: Anthem
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