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Our lawyers and legislative advisors serve domestic and international clients in all areas of corporate and business law, complex litigation, intellectual property, regulatory matters, and government affairs.
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Associate Director/Associate Principal Scientist - Regulatory Affairs International Chemistry Manufacturing & Controls. Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Control - Product Lead page is loaded.
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The Associate Director, US Product CMC Regulatory Affairs is responsible for the coordination and execution of regulatory activities required of an IND/NDA/BLA Holder for compliance to FDA requirements for BI's investigational and US market product portfolio.
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The Associate Director, US Product CMC Regulatory Affairs acts as primary internal contact for all US regulatory relevant topics. Provides US CMC regulatory guidance to international development CMC sub teams in accordance with the CMC Functional Summary Document.
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Directly related clinical trial experience or experience in areas relevant to drug discovery or development, e.g. epidemiology, toxicology, pharmacovigilance, regulatory affairs. The purpose of the Medical Device Safety Scientist Associate Director role is to leverage clinical and scientific expertise working across Lilly's device product portfolio to lead the completion of safety signal detection and clarification, preparation of device safety reviews, support for regulatory inquiries, input into device development and risk management activities, and the promotion and advancement of Global Patient Safety's capabilities in the field of device safety.
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You will be the primary contact to interface with FDA and will lead cross-functional teams to deliver domestic and international regulatory submissions including IND, CTA, NDA and MAA submissions.
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Proven track record of being able to successfully interact with all levels of area, affiliate and internal authority across divisions (including Global Commercial Leaders, Forecasting, Clinical Development, HEOR, Medical Affairs and Regulatory, as well as peer equivalents in other market access teams and the market access community as a whole.
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Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities.
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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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Venable LLP's Real Estate Finance Group seeks a midlevel associate with a minimum of four years of experience to join the practice in the Washington, D.C., Baltimore or Tysons office. Senior Manager of Associate Recruiting.
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You’ll be engaged in projects dealing with International tax, mergers and acquisitions, state and local tax accounting, regulatory processes, tax reporting and strategy. ITS: A career within International Tax Services will provide you with the opportunity to help PwC address their cross border tax needs both locally and globally by managing their global tax rates, finding areas of cost reduction, and responding to inquiries from regulatory authorities.
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You’ll be assisting our team with local tax laws, reporting requirements, statutory filings, corporate strategy, transfer pricing and indirect tax and other international taxation needs. Real Estate: Advise clients on their federal, local and overseas tax affairs, while acting as a strategic consultant related to: deals and transactions (including mergers, acquisitions and investments, conversions, reorganizations, dispositions, joint ventures, fund formation and structuring, etc.
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Demonstrated 10+ years of professional experience in a government affairs, diplomatic, consulting, strategic advisory, or in-house capacity (e.g., government, business, NGO/not-for-profit, or law.
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Oversee the Document Change Control System under the guidance of the Regulatory Affairs Manager & offer general support to the Regulatory Affairs Department as required, assisting in applying regulatory requirements to ensure compliance with local, state, federal, and international authorities.
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Venable LLP’s Commercial Litigation Group seeks a midlevel associate with at least four years of experience to join the practice in the Los Angeles office. The salary range for associate positions is $205,000 to $365,000, depending upon associate level.
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