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Work with Government Affairs to develop positions with respect to key legislative and regulatory developments. Reporting to the Chief Privacy and Innovation Governance Officer, the Chief Privacy Counsel will lead the Privacy Legal team; counsel on high-profile issues related to privacy, cybersecurity, data use, and technology matters; and partner closely with IT, Cigna Information Protection, Data Governance, Digital & Analytics, Government Affairs, and Enterprise Risk Management.
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Oversees all talent billing & production advances with support from Business Affairs manager. Oversees Business Affairs / Talent manger. A minimum of 7 years of experience specific to the advertising industry in a Business Affairs Role.
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We seek outstanding candidates with teaching experience in the following: industry experience in entrepreneurship, drug/ medical device development, data science, regulatory affairs, clinical and medical affairs, quality management, project management, finance, business operations, research and development, biometrics, health economics and outcomes research or manufacturing.
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This position is hybrid, and based in Santa Monica, CA and reports to the Executive Director, CMC Regulatory Affairs. The AD CMC Regulatory Affairs supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies.
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This position works with the Director of Government Affairs and PGE’s state lobby team to formulate and implement PGE’s legislative and regulatory plans at the state level. Develop and implement policy strategies that support affordability for PGE customers, in collaboration with the state lobby team, Rates and Regulatory Affairs, and other internal and external stakeholders.
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The Manager CMC Regulatory Affairs is responsible for supporting the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early and late-stage T cell therapies.
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Collaborate and work cross-functionally with Manufacturing, Regulatory Affairs, Assay Development, Finance, and Quality functions to ensure all activities are scheduled and executed on time in accordance with program timelines.
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Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.
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10 years of relevant experience with either government, prime government contractors, consulting firms, and/or NGO organizations related to national security, defense, information warfare, influence operations, foreign affairs, international development, and other relevant fields.
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Provide PV leadership for Jazz Pharmaceuticals Clinical Development including Clinical, Investigator Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy and operational excellence.
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As a Scientific Affairs Specialist, you will serve as a member of the Scientific & Regulatory Affairs (SRA) team, supporting internal content management, process development and efficiency, and scientific surveillance.
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Reporting to the VP of Global Regulatory Affairs, the candidate will build, drive, and direct the company's regulatory strategy and operations in order to successfully introduce cellular therapies for autoimmune diseases in the clinic.
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Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality metrics for the site. Collaborates with USDA on regulatory compliance activities including regulatory approvals, import/export compliance, traceability, quarantine, safety testing and affidavits.
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Special Skills: Must have strong organizational and leadership skills; good problem-solving skills; demonstrate leadership in the areas of food safety and regulatory affairs; possess a thorough understanding of FDA and/or USDA inspected manufacturing facilities; comprehensive experience with FDA and/or USDA Rules and Regulations.
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Senior Compliance Investigations & Analytics Manager - Los Angeles, CA / Auburn, MA Job Function: Patient Health & Regulatory Affairs. The Senior Compliance Investigations & Analytics Manager is passionate about uncovering insights in the data by using descriptive analytics to tell the story and statistical modeling to recommend action steps that will support an effective Compliance program.
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regulatory affairs jobs Title: regulatory affairs manager Company: Baxter
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