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Support authoring and manage document workflows for planned major submissions including health authority meeting packages, original INDs/CTAs, and protocol amendments:· Lead interactions with external regulatory submissions vendor· Collaborate with internal project team to facilitate IND/CTA document authoring and review workflows including SharePoint and Master Control responsibilities for regulatory affairs and CMC regulatory.
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Must be a law school graduate with an LLB or JD degree Must be admitted to the Pennsylvania Bar.5 or more years of experience working with laws and regulations related to litigation, commercial, energy, and/or regulatory law.
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The Regulatory Law Unit's Airport Division is seeking a licensed Pennsylvania Attorney to fill an Assistant City Solicitor or Deputy City Solicitor position. The attorney will work on a wide range of transactional and compliance matters handled by the Airports Division, including negotiating and drafting of contracts and advising the airport staff on legal and regulatory matters, as necessary, for the City to operate and develop its two airports.
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The Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Regulatory Affairs Specialist.
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The newly established Immune Health Initiative is hiring a full-time Regulatory Affairs Specialist or Senior Regulatory Affairs Specialist to assist with departmental IRB maintenance and submissions and to perform routine internal study monitoring for all observational clinical research studies.
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The CRC B (Regulatory Coordinator) will assist with preparing and processing regulatory documents through the IRB and other research review boards and have the ability to handle a variety of clinical trial related regulatory responsibilities in accordance with University of Pennsylvania, GCP, ICF, and FDA guidelines.
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Biology), with 10+ years of relevant experience or a PhD with 4-6 years of relevant experience Must have demonstrated expertise in global, biologics regulatory CMC Sound understanding of molecular biology and cell culture.
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As a Regulatory Risk Specialist within PNC Investments organization, you will be based in Philadelphia, PA or Bridgewater, NJ.FINRA Series 7,66 (63,65), and 24 requiredJob DescriptionPartners with regulatory risk manager to execute regulatory risk initiatives including setting up, building and monitoring initiatives.
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Director, Corporate Counsel (Rates & Regulatory, Utility) Posted Date: Feb 20, 2024 Location: Camden, NJ, US, 08102 Company: American Water Works Company Inc Share Our Purpose. Director, Corporate Counsel (Rates & Regulatory, Utility) Posted Date: Feb 20, 2024 Location: Camden, NJ, US, 08102 Company: American Water Works Company Inc Share Our Purpose.
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Are you a regulatory affairs and energy policy professional with experience in the RTOs (PJM), FERC and State Commissions? Track Federal Energy Regulatory Commission, PJM, State Public Utilities Commission (PUC), and other federal and state agency policies that impact Companys’ business and coordinate with appropriate functional groups within the Company (Development, Power Marketing, Finance, Asset Management) to ensure policy impacts to our business are understood.
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Our Tax Controversy and Regulatory Services team helps our clients navigate the Internal Revenue Service process to facilitate compliance, drive issue resolution, and assist with strategic forward planning.
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Represent Regulatory Affairs in cross-functional team projects to support clinical trials and registration activities, as needed. Evaluate and develop standard operating procedures for the Regulatory Affairs department.
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This role requires an extensive knowledge of the roles and responsibilities of Regulatory Affairs spanning both clinical and commercial phases of drug development, and how Regulatory Affairs connects with other functional areas.
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The Regulatory Performance Analyst II is a subject matter expert (SME) in assigned compliance area. Responsible for communicating Federal and State regulatory requirements to operational areas within their SME purview and conducting follow up to assure implementation.
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Some of these services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. E. Performing regulatory operations tasks including archiving/assembling/publishing regulatory filings and other health authority communications.
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Title: regulatory Company: Orange Code in Bala Cynwyd, PA
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