• 无工作经验
  • 招1人
  • 11-09 发布

职位描述

职位描述: Develops and implements programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations. Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies. Compiles materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements. Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort and identifies and mitigates areas of risk. Reviews product labeling and marketing materials for accuracy and compliance with regulations. Responds to customers and/or authorities requests/inquiries dealing with regulations and product compliance. Represents company in external bodies dealing with standards and/or product regulations at the national/regional/global level. May assess requirements and identify strategies for earliest possible approvals of clinical trials applications.*Reduces broad concepts, business strategies into structure projects*Leads the design/ delivery of new programs/ solutions; is the key technical contributor*Solves complex, high impact program/ project design problemsBachelors or Masters Degree or University Degree or equivalent.Typically 8+ years relevant experience for entry to this level. Post-graduate and/or certification/ license may be required. Requires specialized depth and/or breadth of expertise in job. Not a natural progression from Advanced level. Agilent is an equal opportunity employer. 职能类别: 生物工程/生物制药

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公司信息

Agilent is a leader in life sciences, diagnostics and applied chemical markets. The company provides laboratories worldwide with instruments, services, consumables, applications and expertise, enabling customers to gain the insights they seek. Agilent’s expertise and trusted collaboration give them the highest confidence in our solutions. Agilent focuses its expertise on six key markets, where we help our customers achieve their goals: Food: Agilent helps ensure that our global food supply is free of contaminants—whether chemical, viral, bacterial or microbiological. Our customers include government regulators and labs that control food safety, as well as private companies that produce, package and sell food to the public. Environmental and Forensics: From pesticides to pharmaceutical residues to trace metals, we provide fast, accurate and sensitive methods for monitoring contaminants affecting quality of life. Agilent solutions also play an important role in law enforcement by providing robust tools and instruments to analyze and verify evidence at trial, and keeping the world’s top-performing athletes honest. Pharmaceutical: Agilent has one of the broadest solutions portfolios of any company serving the pharmaceutical industry. Our solutions provide precise answers for every segment of the pharmaceutical industry, from disease research and drug discovery to drug development, manufacturing and quality control. The start-to-finish solution set means customers can get products to market faster. Customers trust us to help them test the purity of their therapeutics. Agilent also ensures that their instruments and processes conform to the highest compliance regulations. Diagnostics: Agilent gives doctors a head start in the fight against cancer and other diseases. Our solutions help pathology laboratories deliver fast, accurate information to the doctors, hospitals and medical centers they serve. We help medical professionals make more accurate diagnoses so patients can receive the most effective therapies. Chemical and Energy: The world runs on energy, and energy companies need to locate, extract and refine fuels efficiently and cost-effectively. Our solutions help customers maximize their production and predict failures in their refineries before they happen. Agilent also helps energy researchers investigate biofuels, renewable fuels and other forms of alternate energy. Research: Most life sciences and diagnostics research is done at top-tier universities, with funding from governments around the world. Agilent is helping these researchers learn more about cancer, cardiovascular diseases, diabetes, Alzheimer’s, Parkinson’s, autism and other ailments. Our instruments, software and sample preparation solutions help scientists conduct faster, more accurate research. AGILENT RESEARCH LABORATORIES The purpose of Agilent Research Laboratories is to power Agilent’s growth through breakthrough science and technology. To complement our product line R&D, Agilent Labs looks beyond the evolution of current products and platforms to create the technologies that will underlie tomorrow’s breakthroughs, enabling Agilent customers to answer questions at the leading edge of life science, diagnostics and the applied markets. Our horizon is broad, encompassing synergies across Agilent and seeding new businesses to create competitive differentiation and compelling value for current and future customers and shareholders. To accomplish these goals, we attract and retain top technical talent, collaborate extensively with global research leaders in academia, government and industry, and promote a culture of innovation and teamwork across our highly multi-disciplinary staff of life scientists, physical scientists and engineers. The majority of our research is located in the United States in Santa Clara, California, with additional locations in Europe and Asia.

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