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Regulatory, Regulatory affairs, Fda, Regulatory documents, Regulatory submission, Quality assurance, Regulatory compliance, Gmp, Audit, Compliance, Labelling, food safety, food production, food science.
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The CRU Regulatory Affairs Office seeks a full-time Regulatory Affairs Veeva Quality Assurance Specialist to participate in the review and migration of Phase I-V clinical trial investigator site files to the Veeva SiteVault platform.
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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD. Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
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QUALIFICATIONSA scientific degree with directly relevant professional experience in small molecule product development, global CMC regulatory affairs, and CMC technical areas of at least 12 years with a BA/BS or 10 years with an MA/MS, PhD, PharmD, or MD. Demonstrated track record in defining innovative CMC regulatory strategies, and implementing at a platform level.
$237,660 - $307,560ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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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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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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It can be valuable for candidates involved in the development and submission of IVD products to regulatory agencies like the FDA.Regulatory Affairs Certification (RAC): A certification in regulatory affairs, such as the RAC from the Regulatory Affairs Professionals Society (RAPS), can be beneficial for candidates involved in FDA IVD application processes.
$118,000 - $147,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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POSITION OVERVIEW: The Regulatory Affairs, Accreditation & Safety Specialist (RASS) provides regulatory and safety expertise as related to Joint Commission, CMS, Oregon Health Authority, Pharmacy Board, OSHA, and other regulatory agencies.
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Responsible for providing regulatory guidance to IFF Quality team for aspects of product compliance including GMPs and product labeling. Regulatory guidance based on existing statutes and emerging regulatory trends relevant to product compliance, safety determination and efficacy will be key to the success of the role.
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He/she will work in close collaboration with Luminex Research Departments, Regulatory Affairs, Scientific Affairs and Sales & Marketing to ensure effective and efficient conduct of clinical research activities in accordance with applicable regulations and standards (e.g. 21 CFR Part 812, CLSI, ICH) that demonstrate the performance and utility of in vitro diagnostic products.
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This role leads the Optum Legal, Compliance and Regulatory Affairs (LCRA) Executive Council and is a critical member of the UHG LCRA senior leadership team. This Executive Leadership Team (ELT) role reports to the UnitedHealth Group (UHG) Chief Legal Officer and the Optum Chief Executive Officer, provides thought and practical leadership, and is accountable for legal and regulatory affairs teams, programs, and activities across the Optum businesses.
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Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits is required.
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Cititec Talent has partnered with a boutique commodity trading company who looking to bring a Regulatory Reporting Specialist into the business to lead their regulatory reporting consolidation efforts, as they streamline their regulatory reporting solutions for Dodd-Frank and EMIR compliance.
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Professional accreditation such as a Certified Regulatory Compliance Manager (CRCM), Certified Internal Auditor (CIA), Certified Risk Professional (CRP), and Certified Anti-Money Laundering Specialist (CAMS) is preferred.
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Piper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies.
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regulatory affairs specialist jobs Title: compliance specialist Company: Workiva
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