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The Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Regulatory Affairs Specialist.
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May oversee and direct the work of other Regulatory Affairs professionals. Serves as a regulatory liaison for new product development and make regulatory assessments of proposed changes to existing products for impact to regulatory documentation.
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To do these effectively, the Analyst III – Policy & Regulatory Operations must have a demonstrated understanding of IEHP business operations and responsibilities of various departments in Health Services, Quality Systems, Provider Services, and Member Services; subject matter expertise of these departments’ policies and procedures and the regulations that drive their business operations and demonstrated ability to effectively and consistently manage multiple projects and priorities concurrently.
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Mammoth is hiring a Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.
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Sr Director, CMC Regulatory Affairs –Small MoleculesKEY RESPONSIBILITIESThe Sr Director, CMC Regulatory Affairs for Small Molecules is responsible for managing a team of professionals, who work with Gilead’s global portfolio of small molecule products in CMC Regulatory Affairs.
$237,660 - $307,560ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Director, CMC Regulatory Affairs. 15+ 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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The University of Cincinnati, Hoxworth Blood Center is recruiting for a full-time (100 % FTE), Director, Quality Assurance / Regulatory Affairs, to oversee and direct the coordination of quality assurance and regulatory compliance for the Cellular Therapy, Therapeutic Apheresis, and Transplantation Immunology divisions.
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The Principal Scientist provides regional scientific and regulatory expertise and leverages scientific networks to enable the development and execution of Mars Wrigley (MW) Scientific and Regulatory Affairs (SRA) strategy.
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Dexian is seeking a Director, Regulatory Affairs for an opportunity with a client located in Ankeny, IA. Background in food manufacturing or regulatory affairs with companies like Kraft, Kemin, or Land O'Lakes.
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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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Evaluate competitive landscape and various regulatory mechanisms that allow optimization of product development (e.g., orphan drug designation, breakthrough therapy designation, Fast Track, accelerated approval, pediatric plans) and present options and recommendations to expedite the path to market, as applicable.
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As a Director, Regulatory Affairs, Vaccines you will ensure the development and execution of the appropriate Regulatory strategy(ies) for assigned US asset(s), across all stages of the product life cycle and consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP.
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Senior Regulatory Affairs SpecialistWHO WE ARE:NeuroLogica Corp., a subsidiary of Samsung Electronics Co. Ltd., develops, manufactures, and markets innovative imaging technologies and is committed to delivering fast, easy, and accurate diagnostic solutions to healthcare providers.
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Experience in providing regulatory CMC strategy for submission of clinical trial application (IMPD/IND) and marketing authorization application (NDA/MAA) for small molecule development compounds, including chemical drug, peptide and oligonucleotide.
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Collaborate with the Director, DDA, and the Development team to cultivate donors, Board Members, and potential supporters, as an integral part of the curatorial process to generate financial support for the Museum’s curatorial affairs (acquisitions, exhibitions, and special collection projects); and partner with Development to lead and educate the curatorial team on best practices in fundraising and donor cultivation.
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Title: director regulatory affairs Company: Regeneron
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