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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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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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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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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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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 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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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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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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Our client is currently seeking a Regulatory Affairs for a 12 month + contract. Knowledge of regulatory guidance documents (FDA, Health Canada, EU MDR) for determining if a product change requires a regulatory submission (software and hardware devices.
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Lead the regulatory affairs and quality systems efforts, fostering a culture of quality and compliance. 5+ years of experience in global quality systems and regulatory affairs for medical devices.
$250,000 a yearFull-timeRemoteExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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1.0 FTE Full time Day - 08 Hour R2441623 Onsite 108752006 Regulatory Affairs - Quality Mgmt Other PALO ALTO, 900 Welch Rd, California. The Senior Director of Quality Management and Regulatory Affairs is responsible for the strategic planning, oversight and direction of accreditation, regulatory, and licensing across Stanford Health Care. This includes but not limited to continuous readiness plans, peer review process, and care improvement committee responsibilities.
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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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Kelly® Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a 1-year 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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The (Sr.) VP/Head of Regulatory Affairs will lead the company’s regulatory strategy and operations. Establish and maintain regulatory affairs systems, ensuring accurate record-keeping and data management.
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affairs job Title: regulatory in Sunnyvale, CA
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