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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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You will collaborate with Medical Affairs Technology and Medical Excellence personnel, Legal and Regulatory personnel and Medical Affairs colleagues to evolve our content oversight, management and CRM platforms to enable an efficient review and approval of materials, ensure the proper storage and fulfillment of materials, and track how of our medical content is used externally.
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As we expand our portfolio and prepare for commercial entry to the oncology market in the US and EU, we have an exciting opportunity for a Sr Director, Regulatory Affairs - Advertising, Promotion, and Labeling to support the commercialization of our late-stage programs.
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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.
$250ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Partner with the in-country RA team as well as the Product Localization Engineering (PLE) and other cross-functional supporting teams, make sure the company's regulatory affairs activities are conducted accurately, ethically based upon the latest relevant regulations and standards, so that regulatory compliance against China requirement is ensured for all relevant aspects throughout the lifecycle of the products subject to China market.
$112,300 - $190,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Knowledge of regulatory guidance documents (FDA, Health Canada, EU MDR) for determining if a product change requires a regulatory submission (software and hardware devices). Performs review of promotional material for regulatory compliance according to country specific requirements.
ExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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The 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 - $307,560 a yearFull-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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Provider Data Analyst Sr - Regulatory Affairs Department. Experience and knowledge of Network Adequacy regulations or regulatory compliance strongly preferred. Performs provider data analysis and reporting in response to external request from providers and/or regulatory agencies in which the analysis of data requires an evaluation of intangible variables.
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The Sr. Operational Excellence (OpEx) Engineer will be responsible to support the Regulatory Affairs & Quality Assurance (RAQA) organization and some strategic business related programs to achive the annual improvement goals.
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Working with the product leads, the Sr. Manager CMC Regulatory Affairs provides strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls.
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This role is expected to closely collaborate with multiple teams across Process Development, MSAT, Analytical Development, Regulatory Affairs, Quality and Manufacturing. Author and review plans, protocols, technical reports and CMC sections of regulatory submissions.
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The Senior Regulatory Affairs Specialist provides regulatory guidance to cross-functional teams; develops global regulatory strategies; advises on labeling and marketing materials for regulatory compliance; and evaluates product changes for impact on regulatory filings worldwide.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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A clinical-stage bio pharmaceutical client whose mission is to develop new therapies for people with rare diseases is looking for a Regulatory Affairs Specialist with pharmaceutical and/or biotechnology experience.
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At Mainspring, the Manager of Environmental Permitting & Compliance will join a team that sits at the intersection of engineering, sales, installation, maintenance, and regulatory affairs to ensure that our facilities and projects comply with all applicable air quality standards and regulations.
$115,000 - $175,000 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Work closely with and provide quality oversight across functions (across network site QA, Global RM and Regents QC and Tech Excellence, Supply Chain, SQM, Process Development, Regulatory Affairs, Manufacturing) within Kite and externally to assure compliance and strong relationships.
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regulatory affairs jobs Title: sr in Menlo Park, CA
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