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6-8 years of relevant experience in the biopharmaceutical industry, with at least 5 years focused on CMC Regulatory Affairs for biologics. Experience in managing interactions with regulatory health authorities and submitting CTA/IND and BLA/MAA filings, particularly related to gene therapy.
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We invested in new offices, sector teams and practice groups including 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.
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JOB TITLE: Writing Instru ctor REPORT TO: Di rector of Academic Affairs DEPARTMENT: Academic Affairs POSITION TYPE: Seasonal part-time — Autumn FLSA: Exempt SUMMARY: Oliver Scholars seeks a Writing instructor to plan and implement a curriculum for eighth grade students.
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The Global Scientific Affairs COVID & Flu Senior Manager will play a key role in delivering in-house RWE projects and support the development of Vaccines and Antivirals strategy to keep up with the evolving RWE landscape.
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You will work closely with members of the firm’s lines of business, Legal Department, Global Government Relations and Office of Regulatory Affairs to help coordinate the firm’s response to proposed rules and regulations.
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Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression. Own the drug substance modules in the regulatory dossier and collaborate with regulatory affairs to support regulatory submissions and inspections.
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The Senior Scientist supports the Center for Outcomes Research, Real-world Evidence and Epidemiology (CORE) team in Global Medical Affairs. Engage with cross-functional teams in medical affairs strategy, commercial, market access, safety, legal.
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The Communications Advisor will report directly to the office of the Chief Medical Officer/Executive Deputy Commissioner (CMO) and will work closely with the Office of External Affairs to promote the priorities of the CMO and Chief Equity Officer, including CHECW’s health equity agenda.
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Responsibilities: The following regulatory duties will be performed under general supervision by the Assistant Director of Regulatory Affairs and/or Clinical Trials Manager-Regulatory Affairs: 1.
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Attorney will be assigned to the Claims and Litigation Division of the Office of Legal Affairs. NYC Health + Hospitals is the largest public health care system in the United States. At NYC Health + Hospitals, our mission is to deliver high quality care health services, without exception.
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Job DescriptionThe PositionReporting to the Executive Director in Organon's Regulatory Chemistry, Manufacturing and Controls (CMC) New Products, the Senior Scientist is responsible for implementing Regulatory Chemistry, Manufacturing & Controls strategies for assigned biological products including biosimilars in accordance with global regulations, guidances and defined regulatory strategies.
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Manage and oversee all reporting for City, State, and Federal grants, including bi-annual and quarterly reports for the NYC Department of Cultural Affairs and the Upper Manhattan Empowerment Zone Development Corporation.
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Business Affairs, Inc. (BAI) is a boutique entertainment law firm that represents producers, distributors, sales agents and financiers (among others) of motion picture, television, and new media projects.
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Tactical delivery of programs according to established objectives and serves as a resource for education and dissemination of pertinent, clear, and balanced medical-scientific information to internal audiences (Marketing, Medical Affairs, Research & Development and Sales) and external audiences (healthcare professionals, consumers, patient organizations, distributors, etc.
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Director, Model Validation for SHUSA Compliance models (Transaction Monitoring, Sanctions Screening, Fraud Risk, etc) will be responsible for leading the independent validation of models used by various Compliance groups in conformance with regulatory guidance on model risk SR- and other regulatory requirements around Compliance models.
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regulatory affairs jobs Title: sales representative Company: Vector Marketing in New York, NY
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