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Comprehensive understanding of related disciplines (biostatistics, regulatory affairs, pharmacology, toxicology, cell therapy manufacturing, clinical pharmacology, and pharmaceutical sciences.
$350,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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You have experience with US regulatory affairs submissions such as 510(k) and/or PMA. You have at least 10 years of experience in this field so far in your career. You are a seasoned professional in the Regulatory Affairs space with specific experience with IVD and POC products.
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The position is responsible for leading CMC regulatory activities within Regulatory Affairs department, to support all ORIC’s clinical development programs of oncology products. Work collaboratively with Pharmaceutical Science for drug substance and drug product development, GMP Quality Assurance, in addition to Project Management, Clinical Operations, Clinical Supply, and Regulatory Operations.
$235,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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The Executive Director, Regulatory Affairs will develop and execute global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease ensuring fast to market global product registrations, product promotion, maintenance of products and processes in regulatory compliance with local regulations.
$315,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Reporting to the Senior Vice President, Corporate Affairs, the Vice President of Government Affairs & Policy will play a lead role in developing and implementing Crinetics’ federal and state legislative, regulatory and policy strategies to support the business as a whole and specifically business functions impacted by public policy.
$376,000 a yearFull-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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8+ years relevant experience in quality control, quality assurance, and regulatory affairs at a Class I or Class II medical device manufacturer. Coordinate and organize test data and clinical or scientific reviews in support of regulatory submissions.
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Develops, updates and maintains installation EFMP education, outreach and public affairs programs, to include awareness briefings for command, unit, community organizations, individuals and families and distinguished visitors.
Full-timeExpandApply NowActive JobUpdated 30 days ago - UpvoteDownvoteShare Job
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Regularly interfaces with team members in R&D including Biostatistics and SAS Programming staff, Data Management, clinical research and operations teams, regulatory affairs, clinical pharmacology, medical writing, medical affairs and quality management.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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This position will work cross-functionally with biostatisticians, clinical data management, Clinical Operations, Clinical Development, Biomarker, Bioanalytical, Regulatory Affairs, Quality Assurance, and IT, as needed.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Tellus seeks an Environmental Regulatory Specialist who will interface with managers, consultants, and responsible parties to facilitate UST program improvements at the Los Angeles Regional Water Quality Control Board.
Full-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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Bachelor’s degree in life science and 10+ years of experience in regulatory affairs in the pharmaceutical/biotech industry. Regulatory expertise in project leadership, preferably negotiation with and conduct of meetings with the FDA and successful preparation and submission of IND/CTA/MAA/NDA/BLA with explicit CMC focus for biologics and/or small molecule modalities.
$241,925 a yearFull-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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Supports Regulatory Affairs with regulatory agency submissions for new product development by providing clinical trial data review, synopses, and reports for those submissions. Regulatory Compliance: Performs Institutional Review Board (IRB) submission efforts related to LifeNet Health research and development team determinations.
$185,284 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Regulatory Manager i s a key role within the RWE Clean Energy (RWECE) Regulatory Team. You will focus on monitoring and advocating for market policies that will advance the interests of RWECE within the Western interconnect.
$179,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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This includes legal services for large construction projects, procurement of equipment and services, energy transactions (renewables, energy storage, electric vehicle infrastructure, emerging energy technologies), CPUC tariff / regulatory program contracts, federal contracts, financings and collateral, municipal affairs, brand protection and marketing, intellectual property licensing, and legal counseling on a wide range of legal topics to all SDG&E business units.
$301,800 a yearFull-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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The division of Medical Education within the UC San Diego School of Medicine consists of the following units: Undergraduate Medical Education, Admissions & Student Affairs, Diversity and Community Partnerships, Graduate Medical Education, Continuing Medical Education & Faculty Development, Simulation Education, Physician Assistant Education, Anatomical Services, Business Affairs and Educational Technology.
$66.67 an hourFull-timeExpandApply NowActive JobUpdated 21 days ago
regulatory affairs jobs Title: information security in San Diego, Beech-grove, Indiana
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