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The Regulatory Affairs Specialist- Contractor will assist or lead a variety of regulatory tasks in support of global regulatory strategy, regulatory assessment for modified product, regulatory filing for new/modified product, regulatory operation and processes, post-market surveillance.
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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.
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Our Client's FDA regulatory group works with broad range of companies, including medical devices, drugs, biologics, diagnostics, digital health, research tools, cosmetics, dietary supplements, wellness products, and other consumer products.
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Collaborate with cross-functional teams (process R&D, analytical development, supply chain, quality, clinical, regulatory, DMPK, and tox) to meet CMC and program goals. Extensive experience in late-phase drug product development and commercial development with CMC regulatory filings for the US (NDA), Europe (MAA), Japan, and China.
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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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Prior experience in healthcare and/or digital health marketing with awareness of the regulatory issues and understanding of promotional regulatory requirements. At least 3 years prior experience in search engine optimization (SEO), search engine marketing (SEM), content marketing, email marketing, digital advertising, and social media marketing.
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Responsible for all aspects of product design, including modelling, key component selection, schematic capture, PCB layout, code development, magnetics design, thermal design, regulatory and compliance considerations, DFM.
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Regulatory Compliance: Stay informed about regulatory requirements and industry best practices related to cryptocurrency trading, and ensure that the platform complies with relevant regulations.
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Duties: Serve as the System Manager for IT Systems enabling commercial and Medical Affairs business processes with technology platforms such as Veeva CRM, Commercial Data warehouse, Salesforce Marketing Cloud, Veeva PromoMats, Veeva MedComms, Case Management, Grant Management etc.
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The Freeman Spogli Institute for International Studies (FSI) is Stanford University’s premier hub for interdisciplinary teaching and research on international policy and affairs. Desire to learn about international affairs and use that knowledge for effective stewardship and donor engagement.
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You will collaborate closely with multiple teams across Process Development, Analytical Development, Regulatory Affairs, Quality and Manufacturing. You will collaborate closely with multiple teams across Process Development, Analytical Development, Regulatory Affairs, Quality and Manufacturing.
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This exciting and influential role will serve as Synopsys' strategist and engagement lead for State and Local Government Affairs, including legislative, regulatory and policy objectives and ensure the integration and execution of these objectives to support the State and Local and broader Government Affairs strategy.
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The right candidate will have a basic understanding of and enthusiastic belief in the cryptocurrency/digital asset space, 5+ years of relevant litigation and regulatory experience at a top law firm or in-house at a fast-paced, brand-name business, and possess strong academic credentials and excellent writing and analytical skills.
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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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Experience working with govt affairs, and other trade and regulatory bodies within Cisco and external to Cisco. Represent global manufacturing operations and supply chain in multidisciplinary govt affairs and trade team conversations where applicable.
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regulatory affairs jobs Title: sr Company: Csl Behring in Sunnyvale, CA
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