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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 - $307,560Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Familiar with regulatory standards and quality systems (e.g., GLP, GMP). Associate Director, Analytical Development, Raw Materials. Extensive hands-on experience in a wide range of analytical techniques, such as UV-Vis, HPLC, CE, SDS-PAGE, icIEF, LCMS, GCMS, enzyme kinetics, colorimetric and fluorescent plate-based assays, ELISA, Western Blot, etc.
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Meta is seeking a highly motivated, organized, detail-oriented candidate to assist the Payments Compliance Team as an Investigator on the Transaction Monitoring Team. The Transaction Monitoring team manages reviews of platform transaction activity for potential red flag identification and regulatory reporting.
$90,000 - $137,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Ensure that each group has appropriate protocols to support tech transfer including process development, QA/QC, and regulatory. Experience interacting with government regulatory agencies is a plus (FDA, DEA, etc.
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Requires Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Industrial Engineering Management, Regulatory Affairs, Regulatory Science, or related field and 7 years of progressive post-baccalaureate experience as a quality engineer, validation engineer or any quality assurance occupation in medical device or regulated industry.
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The Senior Research Scientist I will be responsible for lead optimization, API form selection/characterization, pre-formulation, formulation development, manufacture of clinical supplies, development of efficient and scalable manufacturing processes, process scale up based on Quality by Design (QbD), implementation of innovative technologies, CMO management and global regulatory strategy.
$177,905 - $230,230 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Experience advising clients that conduct business in a regulated financial industry and/or other familiarity with applicable legal and regulatory landscapes (e.g., investment adviser, broker-dealer, mortgage, banking, money transmitter.
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Thorough understanding of clinical trial design and reporting processes, and regulatory reporting requirements including electronic data submissions, and CDISC implementation. Ensure quality of deliverables by consistently applying analysis and reporting standards and driving compliance with regulatory requirements, corporate, and departmental SOPs, and work practices.
$165,000 - $225,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Reporting to the Director- EH&S, the Environmental Health and Safety Specialist is responsible for supporting regulatory compliance within the hospital system. Familiar with Cal OSHA, Cal EPA, Bay Area Air Quality Management District, CUPAs, fire departments and similar regulatory agencies.
$88,400 - $117,228.8 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead's products.
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Manage and drive strategy for high-profile litigation and pre-litigation matters, including regulatory litigation, consumer class actions, antitrust, constitutional, and commercial disputes, and other content-related matters.
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Knowledge of state & federal OSHA, US Coast Guard regulations, PSMSC and other safety regulatory requirements for the maritime industry. The Company serves as stevedore and/or terminal operator for a wide variety of maritime cargoes for export and import.
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Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials.
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The key functions of this role will be to collaborate with internal and external stakeholders including the Foster City Medical Affairs team, Scientific Publications, Medical Affairs Research, Marketing, Global Commercial Product Strategy, Value and Market Access, Clinical Research, Public Affairs, Government Affairs, Contracts/Finance, Pharmacology, Virology and Legal on both the global and regional levels.
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The Senior Regulatory Affairs Specialist is responsible for developing strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain existing products, provide advice on regulatory requirements, prepare worldwide submissions, and negotiate their approval with global regulatory agencies.
$99,361 - $136,621 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago
regulatory job Title: sr regulatory affairs associate Company: Thermo Fisher Scientific in Foster City, CA
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