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Reporting to the SVP, Government Affairs, the VP Government Affairs is responsible for planning, overseeing, and directing the government affairs function for Baylor Scott and White Health (BSWH), which may include federal, state, and local government affairs, policy research, policy advocacy programs, and other regulatory oversight activities that impact BSWH healthcare operations.
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Build the Regulatory Operations infrastructure and oversee development of standard operating procedures, training materials, and job aids with respect to Regulatory Affairs and Operations.
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You may know us as Wonderful Pistachios, FIJI Water, POM Wonderful, Wonderful Halos Mandarins, JUSTIN Wine, and Teleflora, but we’re all Wonderful – and we have a great opportunity for a Regulatory Affairs Specialist to join our team.
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As a Regulatory Affairs Manager in Gaithersburg, MD, you'll play a pivotal role in channeling our Scientific capabilities to make a positive impact on changing patients' lives. Regulatory Affairs Manager in the Gaithersburg, MD area.
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This role will lead the Regulatory Operations activities within Global Regulatory Affairs. This role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs, and supporting development of Regulatory Operations procedures and practices.
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Associate Regulatory Affairs Specialist. Senior Regulatory Affairs Specialist. Regulatory Affairs Specialist. Cybersecurity Policy Program Director - Global Regulatory Affairs, Strategy, and Policy.
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The Regulatory Affairs Manager monitors regulatory issues within designated areas and identifies opportunities to engage with government agencies including those within the Department of Health and Human Services (HHS) to further advance the mission and priorities of the Immune Deficiency Foundation (IDF.
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A minimum of 10 years of experience in Regulatory Affairs, CMC Biologics (Bachelor's degree requires at least 12 years) Work with VP of Regulatory Affairs to identify resource needs, including consultants and new associates, advising on skills sets to meet needs.
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Serve as liaison for internal regulatory bodies (IRB, IBC, IACUC, Regulatory Affairs, etc.) Experience with regulatory affairs in an academic research environment. Demonstrated knowledge of regulatory guidelines (IRB, IACUC, MUA, etc.
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The Director, Federal Regulatory Affairs will report to the Managing Director, Federal Regulatory Affairs and will provide centralized management of Constellation’s advocacy at the Federal Energy Regulatory Commission (FERC) and other organizations, as appropriate, including all communications with FERC, internal development of positions, participation in proceedings, preparation and filing of pleadings, and informal advocacy.
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Lead study start-up: prepare and submit all required regulatory documents for new study applications; successfully open new studies from inception to accrual. Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional and federal regulations.
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Under the supervision of a Global Virology Regulatory Affairs liaison, the intern will work with various team members in the Gilead Foster City team to support regulatory submissions in the United States and potentially other countries for marketed and investigational products.
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Reporting to the CEO the SVP/VP Global Regulatory Affairs drives the articulation and. In the short-to-mid term the SVP/VP Global Regulatory Affairs primary focus shall be the.
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We are looking for an experienced Regulatory Affairs & Quality Assurance Lead to oversee our Mark I whole-body scanner regulatory submission and maintain market authorisation for our Gemini digital twin platform for compliance and commercial viability.
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The Senior Regulatory Affairs Manager also develops and maintains familiarity with key health plan operational processes to inform our advocacy efforts. The Senior Regulatory Affairs Manager, in collaboration with the Director, LRAC, will lead the federal advocacy efforts through trade associations, including America's Health Insurance Plans (AHIP.
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regulatory affairs jobs Title: regulatory affairs specialist Company: Jazz Pharma
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