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Two or more years of experience in Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience with direct involvement in regulatory submission preparation across all stages of development through to early life cycle submissions.
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Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression. Deep understanding of regulatory requirements and quality standards in pharmaceutical manufacturing.
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A minimum of 6- 10 years’ experience in product stewardship, regulatory affairs, compliance, chemical consultancy, and/or risk assessment. The ideal candidate will have experience in chemical and environmental regulatory compliance, packaging regulatio ns, product stewardship and industrial risk management in the medical device or manufacturing industries.
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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.
$225,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Reporting to the VP of Legal, the incumbent will provide counsel and advice to the business regarding product safety/regulatory affairs, product stewardship, and product risk management.
$150,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Deep knowledge of Regulatory Affairs, FDA, and EU GMPs, particularly in relation to the development, manufacturing, and distribution of veterinary medicinal products. Collaborate closely with Product Development, Manufacturing Sciences & Technology, Regulatory Affairs, Site Quality (QA and QC), and both Internal and External Manufacturing teams to ensure quality integration.
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You will collaborate closely with multiple teams across Process Development, Analytical Development, Regulatory Affairs, Quality and Manufacturing. The Bioprocess Development Associate will develop and optimize protein and protein-conjugate manufacturing processes.
$85,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Just-Evotec Biologics is seeking a Senior Director of Regulatory CMC to join a fast-paced, collaborative and multi-disciplinary team to lead all aspects of regulatory affairs for the advancement of low-cost biotherapeutics manufacturing.
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Extensive relevant job experience in government affairs, public policy, advocacy, and/or related fields, preferably in manufacturing, consumer packaged goods, diversified industrial and/or technology sectors.
$350,000 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Serve as Operations Team Member interacting with Quality Assurance, Quality Control, Research and Development, Manufacturing, and Regulatory Affairs. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products.
$91,100 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Cpl Life Sciences is looking for a Director of Quality CMC Development (Product Development), you will lead and oversee the formulation and process development of animal health products throughout the entire Chemistry and Manufacturing Controls (CMC) lifecycle.
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Responsibilities include writing and approval of documents at all levels, trouble shooting, reviewing the work of Manufacturing and Research and Development personnel. Our Production Supervisor plans, coordinates, and oversees all manufacturing functions including scheduling, managing multiple products, and meeting completion deadlines.
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Collaborating with internal and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO’s, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met.
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The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for providing strategic direction, operational support, and technical expertise for. Actively collaborates with internal teams (Technical Development and Manufacturing, including Supply Chain and Quality, external partners and CROs) to develop and execute robust CMC regulatory strategies.
$199,320 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This Senior Regulatory Affairs Specialist position is an on-site opportunity working out of our Santa Clara, CA location in the Abbott Vascular Division. 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
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