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15+ 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/small molecules.
$113 an hourFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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The Senior Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that advertising and promotion activities meet geography specific regulatory requirements.
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Role: Regulatory Affairs Specialist/PM - Level I. 4 years of Regulatory affairs job experience in the medical device industry. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
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The Global Q&R Internship Program is a two-summer rotational program that provides students with the unique opportunity to gain valuable experience within Quality & Regulatory Affairs functions across Roche sites.
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Job Title: Regulatory Affairs Associate. A Bachelor’s degree in a scientific field, preferably Chemistry or Pharmacy, with 1-3 years of experience, or a Master’s Degree in Regulatory Affairs with a minimum of 3 months of regulatory experience (internship) is required.
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Role: Regulatory Affairs Project Manager. Regulatory operations: BUDI number updates, label reviews, FDA laser report, state manufacturing license etc. On market support: regulatory impact assessments, etc.
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Extensive interaction with departments outside of CMC Regulatory Affairs to define strategy and submission plans. An in-depth knowledge of ICH and regional CMC regulatory requirements, and an understanding of current global and regional trends in CMC Regulatory Affairs.
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We are recruiting for a Regulatory Affairs Project Manager to join our team at the Santa Clara, CA location. In this role, you be responsible for coordinating, planning, preparation, assembly, and review of regulatory strategies and/or submissions to the FDA and other worldwide regulatory agencies as well as daily regulatory operations.
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Minimum of 3 years regulatory affairs experience required with Bachelor's degree. Minimum of 2 years regulatory affairs experience with Advanced degree. Support regulatory intelligence efforts by monitoring for new or changed FDA regulations and guidance documents and new or revised industry standards, assessing for impact, and communicating among the organization.
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Assist regulatory bodies, consultants and government officials in support of product approvals, labels and labeling. Assist with research in assigned markets specific to regulatory processes, product classification, and product registration requirements.
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Regulatory Affairs Associate I. Degree in Regulatory Affairs with a minimum of 3 months of regulatory experience (internship) is required. Help determine regulatory strategies for manufacturing changes and regulatory activities.
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Coordinate and track workflows for regulatory submissions. Ensure regulatory submissions meet global standards. Provide support to Regulatory management as needed. Proficiency in technology use, including MS Office skills (Outlook, Word, Excel, PowerPoint, MS Project), Document Management Systems and Internet resources, is expected.
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8+ years relevant experience in quality control, quality assurance, and regulatory affairs at a Class I or Class II medical device manufacturer. Coordinate and organize test data and clinical or scientific reviews in support of regulatory submissions.
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The Principal Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements.
$151,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR. Role: Sr. Regulatory Affairs Specialist.
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affairs job Title: regulatory affairs in Milpitas, CA
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