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Collaborate with cross-functional teams, such as Regulatory Affairs, Quality Assurance, Medical Affairs, and IT, to address quality and compliance-related issues and drive continuous improvement initiatives.
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Minimum of 4 years combined regulatory affairs, compliance, product development, nutrition or technical related experience required, with strong knowledge of FDA and USDA food regulations.
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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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With minimal direction the incumbent manages the global regulatory CMC activities except Asia for all assigned Taiho Oncology Inc., (TOI) projects; provides strategic regulatory guidance especially for CMC during drug development, approval and post approval processes and commercialization, in coordination with internal staff, Japanese colleagues at Taiho Pharmaceutical Corporation (TPC) and external consultants/contractors.
$197,000 - $232,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Apply DOE and LLNL ES&H regulatory requirements and operation methods for planning compliant work in PLS managed space. Please be aware of recruitment scams where people or entities are misusing the name of Lawrence Livermore National Laboratory (LLNL) to post fake job advertisements.
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Strong understanding of civil engineering principles, construction practices, and regulatory requirements related to stormwater management, wastewater treatment, and sewer systems. Client Management: Serve as the primary point of contact for clients, stakeholders, regulatory agencies, and other project partners, providing regular updates, addressing concerns, and ensuring client satisfaction throughout the project lifecycle.
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Work with Sales & Marketing and Regulatory Affairs departments to determine requirements and attend meetings. The Technical Writer/Graphic Illustrator will be responsible for the planning, preparation, and maintenance of formal documentation, illustrations and photo-realistic rendering software to create visuals.
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Lead the process of clinical trial design, by collaborating closely with the statistician, medical affairs, and regulatory affairs personnel, that appropriately satisfy the needs of the business as determined by marketing and reimbursement organizations.
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Coordinate CDx operational activities with multiple functional areas (Biomarker Research, Regulatory, Pathology, Clinical Science, Biosample Management, Clinical Operations, and Medical Affairs.
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The Own Brands Technical Services team has an opening for a Regulatory Affairs Associate. As part of the Regulatory Affairs team, the RA Associate will be responsible for ensuring faultless compliance of product labeling for several brands within Albertsons Own Brands.
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As a Senior Water Resources Engineer at Terraphase, you will play a critical role in developing and implementing water resource projects, ensuring compliance with regulatory standards, and addressing complex water-related issues.
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Knowledge and experience with other relating environmental regulatory and compliance requirements, including NEPA, CEQA, Wastes, stormwater, drinking water at the state and federal levels. Serve as a primary technical contact for environmental air regulatory compliance and interpret highly complex environmental regulations and legislation, negotiate the best compliance solution with regulators, prepare detailed applications and permit related documents and serve as a resource and/or collaborate with LLNL programs.
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As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation.
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Ensure the implementation of stewardship programs across our BU’s through strong working relationships with leaders in R&D, regulatory, manufacturing, commercial, government affairs and sustainability.
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Ensure compliance with applicable regulatory, code, and industry standard requirements that are identified in the LLNS Prime Contract and provide support to ensure that corporate and regulatory commitments are completed for nuclear quality functions.
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regulatory affairs jobs Title: regulatory affairs manager Company: Real Staffing in Pleasanton, CA
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