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Competency in managing the work products needed to support regulatory permit applications, CEQA documents, and environmental due diligence investigations (e.g., wetland delineations, rare plant surveys, habitat assessments, biological resources technical reports.
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The Director of Safety Regulatory Compliance is responsible for planning, managing, facilitating, and coordinating SMS activities throughout SEPTA. The Director of Safety Regulatory Compliance role encompasses developing and updating safety management policies.
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We are seeking a(an) Director of Regulatory Compliance with Riverside Community Hospital to promote growth and unlock possibilities. The Director of Regulatory Compliance and Accreditation is responsible for administration and oversight of all activities concerning the achievement of continuous regulatory and accreditation readiness, quality excellence, and corporate safety compliance for the organization.
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The Senior Regulatory Affairs Specialist will be responsible for projects by leading biologics CMC regulatory submissions, reviews and approves advertising/promotional materials, provides regulatory input into change controls and CAPAs and support audits/inspections to ensure full compliance for US S+N site.
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Regulatory expertise in project leadership, preferably negotiation with and conduct of meetings with the FDA and successful preparation and submission of IND/CTA/MAA/NDA/BLA with explicit CMC focus for biologics and/or small molecule modalities.
$167,000 - $241,925 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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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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As a Barclays US Basel IV Regulatory Capital Reporting Assistant Vice President (AVP), you will be working in the Regulatory Capital Team and will be tasked with the development and on-going circulation and reporting of both point in time and Comprehensive Capital Analysis and Review (CCAR) Projected risk weighted assets (RWAs), capital leverage, and Single Counterparty Credit Limits (SCCL) Large Exposures for Barclays IHC (Intermediate Holding Company) to internal and external stakeholders.
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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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Manage electronic (Markit counterparty platform) and paper onboarding process to ensure regulatory compliance; Facilitate ISDA Protocol Adherence Letters and Questionnaires. Supervise and facilitate the regulatory onboarding of new derivatives counterparties in an efficient, compliant, and client-centric manner by coordinating with clients to obtain required onboarding documentation.
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UPMC Hillman Cancer Center is currently hiring a regular full-time Regulatory Specialist to help support the Oncology Clinical Research Services team located at the Hillman Cancer Center in Shadyside/Pittsburgh, PA. This role will support multiple Oncology Disease Center program(s) studies working Monday through Friday daylight hours.
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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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Key to the development, structuring and roll out of new technology, intelligent automation and tactical process changes required to drive improvement in onboarding activities and ensure compliance with regulatory reform impacting the business.
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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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Contribute to the development, review and approval of written policies and procedures necessary for compliance with all Reliability Requirements applying to Calpine, specifically as they relate to: Generator Owner (GO) and Generator Operator (GOP) functions as defined by NERC.Assist in tracking regulatory enforcement actions litigated by the CFTC, CME, and FERC, and summarizing pertinent case facts.
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With minimal direction the incumbent manages the global regulatory CMC activities except Asia for all assigned Taiho Oncology Inc., (TOI) projects; provides strategic regulatory guidance especially for CMC during drug development, approval and post approval processes and commercialization, in coordination with internal staff, Japanese colleagues at Taiho Pharmaceutical Corporation (TPC) and external consultants/contractors.
$197,000 - $232,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago
regulatory job Company: Metroplus Health Plan
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