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Regulatory, CMC, drug development, pharmaceutical, biotech, chemical engineering, GMP, IND, IMPD/CTA, NDA, MAA. 10+ 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 and small molecules.
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We seek outstanding candidates with teaching experience in the following: industry experience in entrepreneurship, drug discovery and development, cell and molecular biology, genetics, biochemistry, microbiology, laboratory instruction, biotechnology finance, regulatory affairs, clinical trials, project management, or manufacturing.
$3,527 a monthPart-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Hands-on experience with NGS and DNA/RNA molecular biology is required. Advanced degree in a scientific discipline with a strong background in molecular and cell biology, biotechnology, or biochemistry is required.
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Kelly® Science & Clinical is seeking two experienced Technical Writers for a 6-month contract opportunity with a leading molecular diagnostics company at their headquarters in Sunnyvale, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology industry.
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Kelly® Science & Clinical is currently recruiting for a Technical Writer for a 6-month contract opportunity with a leading molecular diagnostics company at their headquarters in Sunnyvale, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology realm.
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Knowledge of mechanical/thermal design (cooling devices, air flow, temperature, power, cooling, mechanical design) with electrical/power (power distribution, AC power types, power calculations, DC power, regulatory/safety) is a plus.
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Minimum of 5 years of experience as a Developer/Business Systems Analyst with a focus on QMS in the medical device industry, including expertise in Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
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Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. The Sr. Patent Counsel is responsible for partnering with R&D, manufacturing and other business and legal stakeholders to develop and execute strategies to protect and perfect Cepheid’s intellectual property.
$260,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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PhD or master’s in microbiology, molecular Biology or related field. + Ensure that all microbiology testing activities and AST assays developed adhere to relevant regulatory requirements (e.g., FDA, ISO13486 and EU IVDR) and good laboratory practices (GLP.
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QualificationsBachelor’s degree or higher in environmental management, environmental science, physical science, or related fieldMinimum of five years field experience that should include:Project managementClient relationsSite samplingEmergency/spill responseSite characterization and remediationCoordination with permitting and regulatory authoritiesCPESC/CESSWI CertificationDOT/RCRA CertificationCHMM, Hazwoper a plusMust have strong oral and written communication skills.
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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. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.
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Demonstrates extensive knowledge of, and/or a proven record of success performing in a role that emphasizes analyzing client internal control practices and evaluating client compliance with import control regulatory requirements, and some knowledge of international trade and US Customs issues, such as:Associated documentary requirements;Knowledge of the analysis of client internal control practices; and,Knowledge of valuation of client compliance with import control regulatory requirements.
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Who you are 3 - 5+ years' experience as either an in-house compliance officer at a progressive bank, fintech, or related entity, managing payments, banking, and payments industry legal and regulatory compliance, or legal expertise at a top-tier legal & regulatory firm with a focus on regulatory compliance controls across banking & payments industry.
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). We assist companies and non-profit organizations in delivering benefits to their employees.
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If an export authorization from an applicable US regulatory agency is required in connection with your employment, your employment is contingent upon Supernal’s receipt of such regulatory authorization(s) and your continued compliance with all conditions and limitations pursuant to such authorization(s.
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regulatory molecular jobs Title: sr regulatory specialist in San Jose, CA
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